Validation Engineer III
AGC Biologics
- Longmont, CO
- $94,000-129,250 per year
- Permanent
- Full-time
- Prepares/ executes IQ/OQ/PQ protocols for equipment and analytical instruments including related software and computerized systems to ensure CFR Part 11 and Data Integrity compliance.
- Identify, investigate, and resolve validation deviations encountered during IQ/OQ/PQ.
- Plan qualification and validation activities, coordinate cross functional team members and/ or outside service providers and/ or contractors to execute, review and approve validation protocols and reports.
- Generates and reviews qualification report and helps summarize the results which may be viewed by clients and regulatory agencies.
- Performs validation periodic review and re-qualification of equipment and analytical instruments.
- Performs change control validation assessment to determine risk based qualification. requirements for new systems and changes to existing qualified systems.
- Perform validation activities in accordance with procedures, protocols and GMP requirements.
- Participate in process and procedure improvement as part of AGC Biologics continuous quality improvement mission.
- GMP, IQ/OQ/PQ, Analytical Instrument Qualification, Computerized Systems Validation, Equipment IQ/OQ/PQ
- Critical thinking, problem solving skills, experimental design, data evaluation skills.
- Excellent written communication, protocol and report writing skills, technical writing skills.
- Attention to detail.
- Team player who is collaborative with a positive attitude.
- Demonstrates ability to effectively manage multiple tasks utilizing organization and prioritization skills, self-motivated.
- Strong interpersonal, written/oral communication and problem solving skills
- BA or BS with at least 6 years QA-related validation experience or equivalent work experience or a Master degree in a scientific discipline with at least 4 years related experience; may include equivalent work experience in a cGMP manufacturing facility.
- Experience with application of validation compliance and principles of quality which drive QA Validation strategy and oversight.
- Experience in facilitating change control, deviations/investigations, and closure. Knowledge/Experience in Corrective and Preventative Action (CAPA) facilitation and closure.
- Equivalent education and experience may substitute for stated requirements