Validation Engineer - Laboratory Instruments

Pfizer-posted 10 months ago
$66,500 - $110,900/Yr
Full-time • Entry Level
Rocky Mount, NC
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Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is crucial to ensuring that customers and patients receive the medicines they need, precisely when they need them. By collaborating with our forward-thinking engineering team, you will play a key role in accelerating the delivery of medicines to the world. Your innovative ideas and proactive actions will help us imagine new possibilities and bring them to life, ensuring that our solutions are both timely and effective. Your contributions will be essential in ensuring that our manufacturing processes are efficient, reliable, and of the highest quality, ultimately helping us deliver life-saving medicines to those who need them most.

  • Serve as validation representative for laboratory instruments and partner with laboratories, Quality System Administrators, Digital, Instrumentation and Quality Engineering on implementing new instruments at the site.
  • Author cGMP risk assessments, user requirements & functional specifications, validation plans, validation protocols (i.e., IQ, OQ, PQ), traceability matrices, summary reports, decommissioning protocols, and other validation deliverables as required by the site validation SOPs.
  • Initiate and lead risk assessment, gap analysis and deviation management for commissioning of, changes to, or decommissioning of laboratory instruments and associated instrument control software.
  • Assure 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, and 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 stakeholders to mitigate the gaps.
  • Assist system owner with evaluating and recommending the appropriate user roles and privileges for data integrity (where applicable) and with the writing of instrument operation instructions.
  • Perform and/or support periodic reviews of laboratory instruments and associated instrument control software with focus on change control, deviation investigations and the corrective and preventive actions to ensure compliance and validated state of the instrument.
  • High School Diploma (or equivalent) and 6 years of relevant experience OR an Associate Degree with 4 years of relevant experience OR a Bachelor’s Degree with 0+ years of relevant experience.
  • Experience validating a variety of laboratory instruments, including atomic absorption (AA) spectrometer, dimensional measurement systems, genetic analyzer, fourier-transform infrared spectroscopy (FT-IR), ion chromatography (IC), inductively coupled plasma mass spectrometry (ICP-MS), particle counter, total organic carbon (TOC), ultraviolet-visible spectroscopy (UV/Vis), and universal testing (tensile and compression) machines within various quality laboratories (Environmental Control, Chemistry, Microbiology and Manufacturing etc.).
  • Exposure to laboratory operations and scientific processes associated as well as familiarity with a variety of laboratory instruments within various quality laboratories (Environmental Control, Chemistry, Microbiology and Manufacturing etc.).
  • Good working knowledge of Food and Drug Administration (FDA) Regulations/Guidance, and Good Manufacturing Practices (GMP).
  • Understanding of global regulations on data integrity including FDA Title 21 CFR Part 11.
  • Mastery of core computer software/systems (Word, Excel, SharePoint, PowerPoint, Teams, etc.).
  • Ability to work effectively in a team environment and collaborate with cross-functional teams.
  • Experience in a biotechnology or pharmaceutical cGMP manufacturing environment preferred.
  • 1+ years’ experience in performing periodic review of laboratory instruments including those with computerized systems.
  • Experience in identifying shortcomings in the system’s data integrity and FDA 21 CFR Part 11 controls.
  • Ability to adapt to changing priorities and work effectively under pressure.
  • 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
  • Paid vacation, holiday and personal days
  • Paid caregiver/parental and medical leave
  • Health benefits including medical, prescription drug, dental and vision coverage
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