Senior Validation Engineer - Laboratory Instruments
The position of Senior Validation Engineer - Laboratory Instruments is an individual contributor role which, under the guidance of the Manager, is responsible for the validation lifecycle of laboratory instruments within the Quality Laboratories at the Pfizer, Inc. sterile injectable manufacturing facility located in Rocky Mount, North Carolina, USA.
- Serving as validation representative for laboratory instruments and partnering with the laboratories, Quality System Administrators, Business Technology, Instrumentation and Quality Engineering on implementing new instruments at the site.
- Performs periodic review of instrumentation and associated computer systems a needed.
- Initiates and leads risk assessment, gap analysis and deviation management for commissioning of, changes to or decommissioning of laboratory instruments and associated instrument control software where applicable within the Quality Control laboratories.
- Authors cGMP risk assessments, user requirements & functional specifications, validation plans, protocols (i.e. IQ, OQ, PQ), traceability matrices, reports, addendums, decommissioning plans and other validation deliverables as required by the site validation SOPs.
- Ensures lab instrument’s adherence to national and international regulatory guidelines on Electronic Records and Electronic Signatures and Data Integrity, cGMP, FDA 21 CFR Part 11/210/211, EU Annex 11, MHRA guidelines. Authors protocol to challenge the main aspects of these requirements during validation to demonstrate adherence. For systems found unable to fully comply, formulate workarounds/strategies with core stake holders to mitigate the gaps.
- Assists the system owner with evaluating and recommending the appropriate user roles and privileges for data integrity (where applicable), writing instrument operation instructions and setting up preventive maintenance plans.
- Completes periodic reviews of laboratory instruments and associated instrument control software with focus on change control, deviation investigations and CAPA to ensure compliance and validated state of the instrument.
- Reviews validation deliverables created by others for adherence to site validation SOPs and acts as validation approver as needed.
- Supports client and regulatory audits.
- May supervise and/or mentor junior level engineers.
- All other duties as assigned.
- Bachelor’s degree in science, engineering, manufacturing technology or closely related field.
- 3–5 years’ experience in validation of instruments including those with computerized systems (e.g. AA, DNA Sequencer, FT-IR, IC, ICP-MS, Particle Counter, TOC, UV_Vis) in a cGMP environment.
- Excellent attention to detail and working knowledge of FDA Regulations/Guidance, and Good Manufacturing Practices
- Demonstrated understanding of global regulations on data integrity, FDA 21 CFR Part 11 and validation/qualification requirements.
- Ability to manage multiple activities and constantly change priorities.
- Exposure to lab operations and scientific processes associated as well as familiarity with a variety of laboratory instruments within various areas (Biological, Chemical, Environmental Monitoring, Micro, etc.).
- Ability to work both independently and in partnership with others; proven ability to use initiative and drive to achieve results.
- Proven ability to follow a variety of instructions furnished in written, oral, diagram, or schedule form.
- Excellent communication skills, oral and written, and attention to detail.
- Mastery of core computer software/systems (Word, Excel, Sharepoint, etc.).
- Bachelor’s degree in a science or engineering related discipline with knowledge of quality operations laboratory processes.
- 5+ years’ experience in the validation of laboratory instruments including those with computerized systems (e.g. AA, DNA Sequencer, FT-IR, IC, ICP-MS, Particle Counter, TOC, UV_Vis) in a biotechnology or pharmaceutical cGMP manufacturing environment.
- 3+ years’ experience in performing periodic review of laboratory instruments including those with computerized systems.
- Demonstrated expertise in identifying as well as formulating procedural controls to compensate for shortcomings in the system’s data integrity and FDA 21 CFR Part 11 controls.
- Experience with TrackWise CR/PR/CAPA systems.
- Lean Sigma Greenbelt Certification.
- Strong critical thinking and problem-solving skills.
- Mathematical and scientific reasoning ability.
- Occasionally lift a computer system and/or instrument up to 50 pounds.
- Use a computer terminal for up to 8 hours per shift, work around moving equipment, work with biological and chemical materials.
- Stand for up to 8 hours, sit for up to 8 hours, walking, climbing stairs, responding to visual warning indicators, respond to audible warning indicators, respond to color or special visual indicators, wear specialized protective.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Primary work schedule is Day shift, Monday – Friday but evenings, weekends and holidays will be required, as needed to support laboratory processes at the Rocky Mount site.
- Must be able to wear proper gowning and PPE in laboratory and manufacturing areas as required to meet GMP and/or OSHA requirements.
- Work safely in laboratory areas where biological and chemical hazards are present.
- Minimal travel may be required.
Other Job Details:
- Eligible for Employee Referral Bonus
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.Sunshine ActPfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.EEO & Employment EligibilityPfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.Quality Assurance and Control#LI-PFE