Operation Supervisor

Validation Engineer

QC Chemist I

Overview: <ul><li>This position will lead within operations both manufacturing and packaging teams in Somerset, NJ.</li><li>Reporting to one of the operation Managers, operation Supervisors lead teams in designated technology areas and product trains at the site, directs and coordinates the activities of department operators , conduct performance reviews, interact with support departments, and drive efficiencies initiatives within operations.</li><li>The Somerset, NJ site produces oral solid and liquid dosage form pharmaceuticals.</li></ul> Responsibilities: <ul><li>Will lead oral solid dosage form manufacturing and packaging teams as assigned.&nbsp;</li><li>First shift leader with start time 6:00 am to 2:00 pm (8 hr. - 5 days/week) or 5:45 am to 4:00 pm (10 hr, 4 days/week).&nbsp;</li><li>Discussion with Manager on the right fit and team needs.&nbsp;</li><li>Develop, recommend, and implement measures to improve production methods, equipment performance, and quality of product&nbsp;</li><li>Track production processing and material management in SAP&nbsp;</li><li>Daily metrics reporting such as variances in production, labor hours and downtime, track and report operator performance and attendance&nbsp;</li><li>Oversee completion of GPM records and standard operating procedures required within operations&nbsp;</li><li>Participate and develop plans for improving a safe work place and culture of identifying, reporting, and fixing unsafe conditions and behaviors within the site and our work teams.&nbsp;</li><li>Work with cross functional groups to accomplish objectives including finance, procurement, operations, supply chain, maintenance, facilities, technical services, security, quality assurance, and quality control as appropriate.&nbsp;</li><li>Under the direct supervision of a leader and able to communicate progress, needs, requirements, and issues effectively for assigned work for yourself and your teams.&nbsp;</li><li>Carry out all duties in accordance with Good Manufacturing practices (cGMP) and standard operations procedures.&nbsp;</li></ul> Requirements: Qualifications and Education Requirements: <ul><li>Associates degree or higher preferred&nbsp;</li><li>5+ years of pharmaceutical packaging OR manufacturing experience&nbsp;</li><li>2+ years’ experience leading/supervising in a manufacturing environment&nbsp;</li><li>Working knowledge of SAP or another ERP system&nbsp;</li><li>Excellent written communication skills</li></ul>

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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Operation Supervisor

Validation Engineer

QC Chemist I

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Operation Supervisor

Validation Engineer

QC Chemist I

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