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• 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.
• 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.
• 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. 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.
• May supervise and/or mentor junior level engineers.
• All other duties as assigned.
Top 5 Skills -Requirement:
we are looking for is someone who has the experience with the following:
1. Validation of laboratory instruments including those with computer system attached for instrument control (i.e. AA, FT-IR, ICP-MS, TOC, UV_Vis)
2. 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
3. The essence of the Part 11 regulations 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. 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. In addition, the audit trail must capture change
4. Must be able to multi-task - new projects will thrown at the worker constantly, must be able to handle all of them.
5. Detail oriented is a must!
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