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Job Description: ROLE SUMMARY
The Quality Engineer III - Instrument Validation will be responsible for:
• Serving as validation representative for instruments
• Partnering with the laboratories, quality system administrators, BT, instrumentation and quality on implementing new instruments at the site
• Performing analytical instrument validation including computerized system validation if applicable
• Performing any validation change control during the life-cycle of the system
• Performing system periodic review
• Performing 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.
• Initiates and leads change control for implementation of new instruments or changes to existing analytical instrumentation 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), reports, addendums and other validation deliverables as required by the site validation SOPs.
• Assist the system owner with evaluating recommending the appropriate user roles and privileges for data integrity (where applicable), writing instrument operation instructions and preventive maintenance plans.
• 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.
• Initiates and leads risk assessment, gap analysis, and deviation management associated with validation of lab instruments.
• Completes periodic reviews of instruments and instrument control software with focus on change control, deviation investigations, and CAPA to ensure compliance and validated state of the instrument. Previous experience with PR/CAPA systems preferred.
• Reviews validation deliverables created by others for adherence to site validation SOPs and acts as validation approver as needed.
• All other duties as assigned.
• Bachelor’s degree in a science or engineering related discipline with knowledge in quality operations laboratory processes.
• 5-7 years of experience in the validation of laboratory instruments including those with computerized systems attached in a cGMP environment (required).
• 5-7 years of experience in the Pharmaceutical industry or relevant business experience within Quality Assurance or Validation cGMP Compliance.
• Hands on experience operating instrument systems.
• Demonstrated attention to detail.
• Good oral and legible written communication skills.
• Must be able to work independently.
• Mastery of core computer software/systems (Word, Excel, Sharepoint, etc.).
• Demonstrated ability to work in a team environment and manage workload to meet deadlines.
• Ability to follow a variety of instructions furnished in written, oral, diagram, or schedule form.
PHYSICAL/MENTAL REQUIREMENTS (not all roles will have physical or mental requirements)
• Use a computer terminal for up to 8 hours per shift, occasionally lift a maximum of 5 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.
• Mathematical and scientific reasoning ability.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
• May be required to work non-standard hours including weekends and holidays to support laboratory processes at the Rocky Mount site.
• Some gowning may be required to enter laboratory areas.
• Work safely in laboratory areas where biological and chemical hazards are present.
Position interacts with laboratories within the Quality unit and impacts their compliance and continuous improvement. Other functions key to the instrument validation process include Laboratory System Administrators, Calibration and Documentation.
Position Comments visible to MSP and Supplier: Other Considerations:
1. The official job description of the candidate is Quality Engineer III - Laboratory Instrument Validation.
2. If the candidate has less than the required 5-7 years of experience in the validation of laboratory instruments, will consider the candidate for Quality Engineer II - Laboratory Instrument Validation at the rate range of $55-$70/hr.
3. Please post this position in an area geared for the laboratory.
4. In Appendix B, CANDIDATE SCREENING – RESUME COVERSHEET, it would be helpful if the vendors would include the information for at least the 4 skills identified below in addition to anything else they want to add/highlight.
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