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Validation Engineer III

Rocky Mount, NCRandstad LifeSciences

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Job Title:  Validation Engineer III

Job Summary

  • The Senior Validation Engineer - Laboratory Instruments will be responsible for: 
  • Serving as validation representative for laboratory instruments 
  • Partnering with the laboratories, Quality System Administrators, Business Technology, Instrumentation and Quality Engineering on implementing new instruments at the site
  • Performing the following:
    ?    instrument validation including computerized system validation if applicable
    ?    spreadsheet validation
    ?    any validation change control during the life-cycle of the system
    ?    system periodic review
    ?    system decommissioning
    This position will be responsible for providing end-user support for all Quality Laboratory groups as well as compliance to global and site internal policies and procedures.

Job Responsibilities

  • Initiates and leads change control, risk assessment, gap analysis and deviation management for implementation of new laboratory instruments or changes to existing instruments and associated instrument control software where applicable in Quality Control laboratories. 
  • Authors cGMP risk assessments, user requirements & functional specifications, validation plans, protocols (i.e. IQ, OQ, PQ), traceability matrices, reports, addendums 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. Previous experience with Trackwise PR/CAPA systems preferred. 
  • 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.

Education & Qualifications

  • Bachelor’s degree in science, engineering, manufacturing technology or closely related field.
  • 5-7 years of experience in validation of equipment including those with computerized systems in a cGMP environment.
  • 3-5 years of experience in the Pharmaceutical industry or relevant business experience.
  • 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 with various areas (Chemistry, Micro, Bio, EM 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.).
  • Hands on experience operating/validating various laboratory instrument systems (e.g. AA, FT-IR, IC, ICP-MS, TOC, UV_Vis). 
  • 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.
  • Strong critical thinking and problem solving skills.
  • 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.
  • Mathematical and scientific reasoning ability.
  • Use a computer terminal for up to 8 hours per shift, occasionally lift a maximum of 10 pounds per activity 4 times per shift, work around moving equipment, work with biological materials.
  • Occasionally lift a computer system and/or instrument up to 50 pounds.
  • 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.


  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance


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