Job Description

Validation Engineer
Job Number: 19-02500
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Validation Engineer for our client in Rocky Mount, NC
 
Eclaro’s client is among the world’s largest pharmaceutical companies, trusted by billions to provide superior, cutting-edge, and inexpensive medicine that improves health and well-being. If you’re up to the challenge, then take a chance at this rewarding opportunity!
 
Responsibilities:
  • 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
  • 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
  • May supervise and/or mentor junior level engineers
 
Required Experience:
  • 5-7 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 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
  • 3-5 years of experience in performing periodic review of laboratory instruments including those with computerized systems
  • Demonstrated understanding of global regulations on data integrity, FDA 21 CFR Part 11 and validation/qualification requirements
  • Bachelor’s degree in a science or engineering related discipline with knowledge of quality operations laboratory processes
  • 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.)
 
Required Skills:
  • Excellent attention to detail and working knowledge of FDA Regulations/Guidance, and Good Manufacturing Practices
  • Ability to manage multiple activities and constantly change priorities
  • Strong critical thinking and problem solving 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 to configure, test and validate the system 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
  • Must be able to multi-task - new projects will thrown at the worker constantly, must be able to handle all of them
  • Detail oriented
 
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:
Audrei Cortez
audrei.cortez@eclaro.com
2019423017
Audrei Cortez | 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.

Application Instructions

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