Laboratory Systems Analyst

Validation Engineer

Responsibilities:To provide production and project support for laboratory computer systems, including system administration activities related to user account management, desktop support, instrumentation computer builds, hardware and software troubleshooting, technical support, and validation/qualification for new and existing systems. This position will be responsible for providing Information Technology support for the following areas: QA, QC, Support Laboratory data collection and support applications.Primary support for Waters Empower 3 application.Support other lab systems including Malvern Particle Sizers, ICALIS-IDIS, OMNIC FTIR, Bruker XRD, ICP-Mass Spec, Imaging Software, UV/VIS Spectroscopy, Labware LIMS, Proveris Sprayview, LabX, PharmSpec HIAC, Vitek 2, Citrix, and othersSupport and maintain Laboratory application servers, PC workstations.Engage and work with support vendors to resolve issues in a timely manner with an understanding of the root cause.Ensures lab systems daily back-ups are running.Maintain lab file shares.SOP Review and Development.Work with all areas to develop process and technology-based solutions for their business needs.Active participation in all systems implementations and technical development.Manage the compliance level of all systems in accordance with corporate and regulatory standards.Collaborate with other IT areas to address overall systems integrity, compliance, system integration and develop corporate IT/strategy.Manage user requirements Technical support for new implementations and upgrades.Oversee Installation Qualifications (IQs), Operational Qualification (OQs), Performance Qualifications (PQs), 21 CFR part 11 testing, and acceptance testing as requiredInteract with the business to understand business requirements at a functional / procedural level and translating these into technical design.Generate specifications for configuration / development and implementation.Document, train, and assist in system documentation.Manage the full software development lifecycle (SDLC), including associated change management and validation processes.Project Management skills for new implementations and upgrades.Provide ad hoc reports to satisfy client information requestsComputer systems validationValidate new systems or changes to existing systems, including the preparation and execution of qualification protocols.Prepare necessary documents, e.g. user requirements, requirements traceability matrix.Prepare / update systems governance, i.e. Standard Operating Procedures.Perform necessary IT change controls for various systems.Data integrity and archivingRequirements:BS degree or equivalent work experience.Minimum of 5 to 8 years of relevant experience.Pharmaceutical/Life Science experience beneficial.Strong knowledge of Waters Empower 3 application.Experience with common laboratory equipment and software.Experience with GAMP, CSV, CFR 21 Part 11.Database (SQL Server/Oracle) experience a plus.Trackwise Digital experience a plus.Avamar Backup experience a plusSkills & 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.Customer Service - Manages difficult or emotional customer situations; Responds promptly to customer needs; Solicits customer feedback to improve service; Responds to requests for service and assistance; Meets commitments.Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.Organizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time; supports organization's goals and values; Benefits organization through outside activities; Supports affirmative action and respects diversity.Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.Quantity - Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly.Attendance/Punctuality - Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time.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.

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.

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Validation Engineer

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