Regulatory Affairs Manager

Team Leader Engineering

Vulcanization Specialist

ASC - Process Engineer

Process Online Analyzer Specialist

QC Supervisor

ASC Environmental Coordinator

Validation Engineer

QC Chemist I

Job Summary: <ul><li>The Regulatory Affairs Manager is responsible for ensuring that the companys products meet all regulatory requirements and standards in the markets where they are sold. This role involves managing the regulatory approval process, keeping up to date with regulatory changes, and ensuring compliance with all relevant laws and guidelines.&nbsp;</li><li>The Regulatory Affairs Manager will also collaborate with cross-functional teams to provide guidance on regulatory issues and strategies.</li></ul> Responsibilities: Regulatory Compliance and Strategy: <ul><li>Lead and manage regulatory submissions and ensure compliance with local regulations.</li><li>Develop regulatory strategies for the approval and commercialization of products or product changes.</li><li>Keep abreast of changing regulations and ensure the company remains in compliance with evolving regulatory environments.</li></ul> Product Registration and Documentation: <ul><li>Prepare, review, and submit regulatory documents, including product dossiers, to relevant regulatory agencies.</li><li>Coordinate with internal teams to ensure that all necessary documentation for regulatory submissions is accurate and complete.</li><li>Maintain regulatory files and ensure they are up to date and readily accessible.</li></ul> Cross-functional Collaboration: <ul><li>Work closely with marketing teams to provide regulatory input and ensure compliance is integrated into the planning.</li><li>Provide regulatory guidance and support to cross-functional teams, ensuring the timely and successful approval of products or product changes.</li><li>Assist in the preparation of marketing materials and labeling to ensure compliance with regulatory requirements.</li></ul> Regulatory Approval Process: <ul><li>Manage the regulatory approval process for products, product changes, and renewals, ensuring timely approvals in target markets.</li><li>Communicate with regulatory agencies as needed to clarify issues, respond to inquiries, or resolve regulatory concerns.</li></ul> Risk Assessment and Compliance Monitoring: <ul><li>Identify regulatory risks related to marketing, or distribution, and recommend mitigation strategies.</li><li>Monitor product performance post-market to ensure continued compliance with regulatory requirements.</li><li>Review and assess the impact of new or revised regulations on current and future products.</li></ul> Regulatory Affairs Training: <ul><li>Educate and train internal teams on regulatory affairs and compliance requirements.</li><li>Conduct workshops or presentations to ensure team members are aware of regulatory standards and best practices.</li></ul> Regulatory Reporting and Documentation: <ul><li>Maintain and track regulatory submissions and approvals, preparing status reports for senior management.</li><li>Prepare regulatory updates and reports for regulatory authorities, as needed.</li></ul> Audit and Inspection Support: <ul><li>Support internal and external audits related to regulatory compliance.</li><li>Participate in regulatory inspections or audits and manage the documentation and communication during such events.</li></ul> Requirements: Education:&nbsp; <ul><li>Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Regulatory Affairs, or a related field.</li></ul> Experience:&nbsp; <ul><li>5+ years of experience in regulatory affairs, preferably in the relevant industry (e.g., pharmaceuticals, medical devices, direct-to-consumer).</li></ul> Knowledge:&nbsp; <ul><li>In-depth knowledge of local regulatory requirements and regulatory submission processes.</li></ul> Skills: <ul><li>Strong communication, organizational, and project management skills.</li><li>Ability to interpret and apply regulatory guidelines and laws.</li><li>Excellent attention to detail and ability to manage multiple priorities.</li><li>Experience with regulatory submission software and tools.</li><li>Ability to work cross-functionally with different departments and stakeholders.</li></ul>

Responsibilities:Manage day to day team activities of key account focused FAE(Field Application Engineer) team in the FAE US department Manage all HR topics of the team Train new team members in their role as key account focused FAEs Advise and guide team members on key account specific business and technical details Provide FAE US internal second level support for key account escalations  Develop implementation strategies for account specific key elements of technology and product roadmaps.Condense key account FAE feedback into technology and product roadmaps and project pipelines in order to provide a unified voice to the BUs and Corporate R&D.Integrate IDM focused global FAE input and feedback into key account NPI activities, escalation handling, product improvement projects, and product roadmap developmentContribute team input and customer application knowledge to local and global reporting through Account Team meetings, local company meetings, QBRs, TRMs, Competence Centers, Account Summits, Global Sales Meetings Cover team member substitution tasks Cover Engineering Manager substitution tasks Requirements:Solid experience in vacuum engineering, preferably in the SEMI / Display / Solar industries.Extensive exposure to developing products on system or sub-system level preferable in SEMI / Display / Solar industries.University degree in Physics, Chemistry, Microelectronics, Mechanical, Electrical, or Semiconductor related engineering disciplines.Min 7 years experience in vacuum engineering.Affinity for people management and desire to care for individual team members and the whole team.Good communication skills (verbal and written).Awareness of on-time delivery, quality, and meeting commitments.Technical skills in the field of customer processes, valve applications, and / or platforms.Fluent in English (verbal and written) for communication with customersAbility to work in a global matrix organization.

Responsibilities:Lead Technology related innovation projects in collaboration with internal and external customers as well as suppliersIdentify customer requirements and translate them into specifications for company componentsDevelop & maintain interface to elastomer / compound makersExtend network and partnerships with suppliers, customers, and R&D institutionsAcquire and document Technology Know-How about the usage & application within the Semi-industry (lithography, inspection, deposition, etch, etc.)Link, consult and support the colleagues from the different Business Units, product management and development, simulation, production and test laboratory in elastomer topics within CompanyManage company elastomer portfolio and guide the qualification process for new elastomers and decide about the possible scope of application in vacuum valvesRequirements:MSc or PhD Degree as Materials Scientist, Chemist or equivalent, preferably with knowledge on elastomers or rubber materials C(FKM, FFKM, etc.)5+ years of relevant experience, in sealing- surfaces, systems, materials, favoured if within the semiconductor industryKnowledge on analytics and characterization of rubber compoundsGood network with research partners and ideally within the semiconductor industryPolymer chemistry, Rubber processing, Rubber testingUnderstanding of different cure system — sulfur, peroxide, phenol, diamineElastomer properties understandingCompression and transfer mouldingMould cleaning & maintenanceAnodization, Surface preparation for adhesive bondingCleanroom GMPUnderstand sealing applicationChemical instrumentation for FAEnglish and German speaker, any other language will be considered advantageousMust be available to travel globally to suppliers and customers facilities (10-20%)

Role Description:Company is seeking a Senior Process Engineer to join the Transport Technologies Division of Company's Research & Development Center.The Transport Technologies Division conducts research and technology development in the area of transport fuels chemistry and advanced engine technologies.Our research focuses on the co-optimization of fuel and engine systems while we demonstrate the commercial viability of competitive internal combustion engine (ICE) platforms and low climate impact fuels, which will address the environmental and business sustainability of transport fuels for road, marine and aviation applications. The Process Engineer’s primary role is to provide engineering and process optimization support on developing sustainable synthetic fuels and chemicals production facilities including liaison with leading technology and engineering solution providers.Responsibilities:Participate in a unique, world-class project on innovative process design for transport fuels and petrochemicals production.Develop, configure and optimize industrial processes and participate in engineering and process design studies.Address technical challenges associated with adopting new process and retro fitting to existing refinery configurationsPerform financial modeling, cost estimates and projections on transport fuels and petrochemicals.Conduct techno-economic analysis and benchmarking of R&D projects against commercial and existing technologies Analyze the carbon footprint and energy intensity of new and existing refining/petrochemical processes; and suggest process improvements to reduce the carbon footprint and enhance energy efficiency. Liaise with business proponent and engineering teams within company. Mentor and oversee development of young engineers in the area of specialty. Find creative solutions to technical problems, both working individually and within a team.Requirements:Advanced degree in Chemical Engineering or relevant discipline from a recognized and approved program.At least 10 years of experience of process engineering in refining/petrochemicals industry.Experienced in refinery and petrochemical flowsheeting (PFD and P&ID), and equipment sizing and capital cost estimationKnowledgeable about standard refining, petrochemical processes (e.g. fluid catalytic cracking, hydrocracking, reforming,…etc.) and utilities process. Able to conduct detailed techno-economic assessment of R&D projects. Experience with R&D projects, process development and/or scale up is a plus. Strong project management, interpersonal skills and the capability to work effectively across multiple functional departments.

Responsibilities:Provide process analyzer system support to R&D teams, operations, and pilot plant activities utilizing analytical Techniques such as physical property analyzers, chromatography, spectroscopy and chemometrics.Track analyzer performance efficiency, conduct failure analyses, and drive continuous improvements for analyzer performance and applications.Develop and identify new analytical solutions to monitor process composition in real-time.Support the design, selection, installation and commissioning of new process analyzer systems.Carry out investigative studies in oil and gas processing plants related challenges utilizing state-of-the-art portable on-line analyzers. Manage projects for implementations of process analyzer technologies, including calibration and maintenance procedures, installation recommendation and process validation.Support and guide in-house technology development programs.Utilize project management tools in setting work objectives, detailing experimental scope, and timely execution of the projects towards sound technical solutions while maintaining active interactions and collaborations with customers, engineering departments and other collaborators. Issue patents and publications in peer-reviewed journals and primary international conferences.Assess and train less-experienced scientists and engineers on process analyzers and sampling systems.Develop and mentor less experienced scientists. Requirements:Master’s degree in Chemistry or Chemical Engineering, PhD specializing in process analyzers or system sampling design is preferred. At least ten years of experience in field of process monitoring, most of which must have been in process controls, selection and the design of process online analyzers and sampling systems.Sound experience and hands-on skills in chromatography and physical property analyzers in oil and gas/petrochemical industry is preferred.Demonstrated scientific/technical achievements through patents and publications. Experienced in developing process monitoring solutions and technologies, with the ability to implement technologies for research and development for deployment in gas processing, refining, GOSPs, etc. 

Responsibilities:Oversee physical/chemical/microbiological testing and analyses of pharmaceutical raw materials, excipients and finished drug products, including release, stability testing, cleaning verification test, and in-process testing.Supervise daily work of Chemists, Microbiologists and Technicians; provide guidance and directions when necessary. Conduct lab investigations and prepare deviations as needed.  Testing:Execute work schedule, review analysts’ notebooks and supervise analysts in day-to-day operations to ensure the compliance of SOP, cGMP, GLP, DEA regulations and/or MSDS.Understand analytical instrument operation/maint. of HPLC, UV-Vis, FT-IR, GC, dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Expert in analytical instrumentation to assure quality of test results.Review notebooks and instrument logbooks. Release test results to QA or other departments in a timely manner.Ensure timely completion of stability testing, provide data to regulatory groups, and conduct data trending during product shelf life.Perform methods development, transfer, verification and validation activities. Coordinate and assist with evaluation of Process Validations studies.   Documentation Practice, Training and Compliance:Ensure work of staff is in compliance with good documentation practices per company's SOP and cGMP regulations in the laboratory.  Prepare and review laboratory documents such as Laboratory Deviations, Investigations, and Test Methods in a timely manner.Enforce all applicable safety and standards guidelines, DEA regs and/or MSDS in lab. Ensure analysts are trained properly before they conduct corresponding testing.Lab Maintenance:Perform housekeeping on regular basis. Oversee general lab support; sample receiving, chemical inventory and document filing.Enforce safety by ensuring wearing of lab coat, safety shoes, safety glasses while in lab.Monitor ordering of lab supplies.Enforce the control and management of controlled substances.  Staff Development: Evaluate potential candidates for QC; prepare annual performance evals. for chemists.   Prepare chemists and laboratory for FDA and other compliance audits.Ensures adequate resources are trained to support compliance and business initiatives.Requirements:Education & Experience:BS in chemistry, biochemistry, pharmacy, or related discipline. Advanced degree a plus.7+ years of experience in pharmaceutical laboratory.2+ year QC supervisory experience preferred.Knowledge:Working knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS.Proficiency required with laboratory techniques/instruments, such as pipette, burette, oven, UV-vis spectrophotometer, dissolution tester, pH meter, HPLC or GC and analytical balance, etc.Skills & Abilities:Analytical - Synthesizes complex or diverse information; collects and researches data; uses intuition and experience to complement data; designs work flows and procedures.Problem Solving - Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions; works well in group problem solving situations; uses reason even when dealing with emotional topics.Technical Skills - Assesses own strengths and weaknesses; pursues training and development opportunities; strives to continuously build knowledge and skills; shares expertise with others.Interpersonal Skills - Focuses on solving conflict, not blaming; maintains confidentiality; listens to others without interrupting; keeps emotions under control; open to other ideas and tries new things.Planning/Organizing – Prioritizes/plans work; uses time efficiently; plans for additional resources; sets goals/objectives; organizes/schedules other people and tasks; develops realistic action plans.Safety and Security - Observes safety and security procedures; determines appropriate action beyond guidelines; reports potentially unsafe conditions; uses equipment and materials properly.Dependability - Follows instructions, responds to management direction; takes responsibility for own actions; keeps commitments; commits to long hours of work when necessary to reach goals; completes tasks on time or notifies appropriate person with an alternate plan.Initiative - Volunteers readily; undertakes self-development activities; seeks increased responsibilities; takes independent actions and calculated risks; looks for and takes advantage of opportunities; asks for and offers help when needed.Good verbal and written communications with basic computer skills.Physical Requirements:Extended periods of sitting, standing and walking; use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; talk or hear; and taste or smell, looking at monitor, moderate noise levels and some bus. travel. Work is performed in a FDA and DEA-regulated pharmaceutical lab environment with risk of exposure to various chemicals.Must occasionally lift and/or move up to 25 pounds. Lab coat and safety glasses required in work environment. Specific visions abilities are required by this job include close vision and color vision.The noise level in the work environment is usually moderate. The work environment is representative of a group laboratory environment. 

Responsibilities:Implements the corporate environmental policy and monitors compliance, whilst staying current with all applicable Company and National environmental regulations, standards, procedures, and guidelines as well as all Saudi environmental, environmental health and industrial hygiene programs.This includes the supervision and coordination of local surveys and sampling, the interpretation of measurement results, and reviewing (and commenting) environmental aspects of contract documents as well as monitoring the environmental performance of contractor operations.Responds to concerns and requests for information from EPD, and obtains technical advice from EPD as needed. Provides regular input to management on KPIs and other indicators used to monitor environmental and health performance.Recognizes the process and techniques used to identify, analyze and manage environmental risks as a result of business operations.Organizes and participates in major surveys such as Environmental Performance Assessments (EPAs), Naturally Occurring Radioactive Material (NORM) surveys, Occupational Health Hazard Assessments (OHHAs), HAZCOM Assessments, Chemical Handling Assessments, Waste Management Compliance Audits, and Environmental Health surveys.Actively seeks to resolve any findings from these surveys.Provides follow-up information and updates reports to EPD as required.Coordinates all EMS-related activities within the organization as appropriate, including the development of environmental objectives and indicators, tracking of performance and costs, and record-keeping and reporting functions.Requirements:Bachelors degree (or higher) in Environment or in Chemistry, Biology, civil engineering with Environment related experience or MSc in EnvironmentOver 10 years in Oil and Gas industry environment related experience.Experience in handling projects/tasks related to waste management, water conservation, energy efficiency. EMS ISO:14001 certificated or Experience in leading/conduction EMS audits & other environment related auditsProficiency in English (Read and write)Proficiency in preparing & presenting environmental reports and presentations.

Responsibilities:The Validation Engineer works alone and as part of the Engineering Department to author and execute IQ/OQ/PQ protocols, engineering studies, facility qualifications and other documents related to production and business systems.They will also be responsible for engineering and maintenance projects, such as repairs, upgrades or replacements as the need arises.They will work with quality, technical operations and production to identify and resolve issues. Adhere to all company and cGMP procedures as well as applicable safety regulations.Author change controls, SOPs and protocols.Protocols o Generates and executes validation protocols, and summarizes studies to ensure compliance with manufacturer and SPI specifications, with current Good Manufacturing Practices, and national standards.Responsible for confirming all communicated validation plans to applicable management.Provides technical assistance in the form of rationales or validation studies.Responsible for effectively adopting modern validation techniques, current industry practices, risk management principles, science-based approaches and a strong understanding of processes and equipment.Troubleshoots and resolves issues as needed.Manage multiple projects with competing deadlines.Manage external resources to complete tasks outside SPI’s capabilities. Manage approvers of documents and procedures and ensure timely closure of tasks.Manage project-related Change Requests form initiation through closure, including presentation to Change Control Committee.Assist with deviation investigation and identify areas for CAPAs as needed based on root causes.Source and procure equipment, supplies and other materials as needed.Develop and maintain cross-functional relationships. Requirements:Bachelor of Science in Engineering or Science discipline preferred.Experience in pharmaceutical (i.e. Validation/QA or R&D), medical device, biotechnology industries.In-depth knowledge of the pharmaceutical plant operations is an asset.Proficient in Microsoft Word, Excel, Power Point, Project, AutoCAD and other software relevant to the performance of the JobExperience authoring change controls in Trackwise or other management system.Experience authoring SOPs in MasterControl or other management system.Integrity – Works with integrity and ethically; Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.Collaboration – Works well in group problem solving situations; Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions. People – Treats people with respect; Keeps commitments; inspires the trust of others; Demonstrates knowledge of EEO policy; Shows respect and sensitivity for cultural differences; promotes a harassment-free environment.Responsive – Identifies and adapts to priority issues as they arise; Communicates with management and team members effectively; Works quickly and efficiently.Proactive – Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions.Organized – Tracks deadlines and adheres to schedules; Writes clearly and informatively; Presents numerical data effectively.Learning Mindset – Adapts to unfamiliar situations as needed; Open to new ideas and methods; Readily familiarizes self with new equipment and processes.Regularly lift and /or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.Climb ladders and work in high, precarious places up to elevations of 75 feet.Regularly exposed to work near moving mechanical parts.Exposed to wet or humid conditions.Exposed to outdoor weather conditions.Regularly exposed to high noise environments.Exposed to extremely dusty environments.Exposed to chemicals used in the manufacturing process.

Responsibilities:The Chemist I, under direct supervision, learns and performs QC laboratory chemical analyses of raw materials, in-process materials, stability and finished products, and testing to support process validation.May participate in investigations.Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing.Conducts routine laboratory analyses: finished product testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing.Typical activities may include buffer/solution preparation, standard preparation and operating analytical instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Uses laboratory software for analyses.Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeepingCleans lab working surfaces and disposes of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals.Under close supervision, learns to troubleshoot basic instrument problems.With guidance, participates in OOS/OOT/NOE and other investigations.Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor.May assist in drafting, editing, and reviewing SOPs and laboratory investigations.Maintains assigned training records current and in-compliance.May assist in the training of less senior laboratory staff.Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting.Document accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs.Follows internal processes related to controlled substances continuous.Follows EH&S procedures to ensure a safe work environment.Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS continuous.Requirements:Minimal acceptable level of education, work experience and certifications required for the job.Bachelor of Science Degree in chemistry, chemical engineering or related field with analytical chemistry coursework required. Some pharmaceutical laboratory experience preferred.Proficiency in a body of information required for the job.e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.Proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Basic knowledge of wet chemistry techniques.Knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS.Competency in Microsoft Office Suite.Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.Ability to display and analyze data in a logical manner.Good verbal and written communication skills as well as good computer skills.Attention to details and accurate record keeping.Establish and maintain cooperative working relationships with othersSolid organizational skills.Ability to take initiative, set priorities and follow through on assignments.Physical & mental requirements e.g., lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicalsMust occasionally lift and/or move up to 15-25 lbs.Ability to wear personal protective equipment, including respirators, gloves, etc. Specific visions abilities are required by this job include close vision and color vision.Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods.

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9 wet chemistry Jobs found

Regulatory Affairs Manager

Team Leader Engineering

Vulcanization Specialist

ASC - Process Engineer

Process Online Analyzer Specialist

QC Supervisor

ASC Environmental Coordinator

Validation Engineer

QC Chemist I

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9 wet chemistry Jobs found

Regulatory Affairs Manager

Team Leader Engineering

Vulcanization Specialist

ASC - Process Engineer

Process Online Analyzer Specialist

QC Supervisor

ASC Environmental Coordinator

Validation Engineer

QC Chemist I

WhiteCrow WhiteCrow is on a mission to connect companies with the best talent across the globe.

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