Job Description

Lab Instrument Validation Engineer
Job Number: 19-04163
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Lab Instrument Validation Engineer for our client in Rocky Mount, NC.
 
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
 
 

Responsibilities:
  • Serves as validation representative for laboratory instruments and partners with the laboratories, Quality System Administrators, Business Technology, Instrumentation and Quality Engineering on implementing new instruments at the site
  • 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 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
  • 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
Required Skills:
  • Validation of laboratory instruments including those with computer system attached for instrument control (i.e. AA, FT-IR, ICP-MS, TOC, UV_Vis)
  • Experience with configuring, testing and validating the laboratory systems to demonstrate compliance with 21 CFR Part 11/Annex 11 as well as proposing procedural controls if the system is unable to fully meet the requirements
  • Hands on experience operating the instrument systems to be able to write test scripts to demonstrate the essence of the Part 11 regulations which is to ensure that electronic records and signatures are trustworthy, reliable, and generally equivalent to paper records and handwritten signatures. As such the electronic records should not be susceptible to unauthorized access, alteration/modification, deletion, or other methods of falsification and the audit trail must capture changes. These records need to be accurate and be accessible/available for the duration of data retention period in case it is needed for regulatory or other audits.
  • Must be able to multi-task – new/multiple projects will be thrown at the worker constantly, must be able to handle all of them.
  • Detail oriented is a must! 
Required Experience:
  • 3-5 years of experience in the validation of laboratory instruments including those with computerized systems attached in a biotechnology or pharmaceutical cGMP manufacturing environment
  • Hands on experience validating various laboratory instrument systems (e.g. PerkinElmer AA, FT-IR, Climet CI-150t, IC, Agilent ICP-MS, Instron 5965, Keyence IM-7030, SmartScope Flash 500, 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
  • Demonstrated understanding of global regulations on data integrity, FDA 21 CFR Part 11 and validation/qualification requirements
  • Excellent attention to detail and working knowledge of FDA Regulations/Guidance, and Good Manufacturing Practices
  • Bachelor’s degree in a science or engineering related discipline with knowledge of quality operations laboratory processes
  • 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, Biological, EM etc.)
  • Strong critical thinking and problem solving skills

If hired, you will enjoy the following Eclaro Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • Commuter Check Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
 
If interested, you may contact:
Jane Bautista

froilyn.bautista@eclaro.com
2012858622
Jane Bautista | LinkedIn

Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

 

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