Quality Assurance/Validation Engineer IV (Engineering)
Quality Assurance Specialist/Validation Engineer
North York, ON
Not supervisory role Not hybrid – Onsite
1. Provide technical support to the design and validation of a biological manufacturing facility and process.
2. Provide Quality final review of associated documentation in conjunction with the Quality Leadership team
3. Responsible of technical and Quality review of development documentation for GMP compliance, business risk, and consistency.
4. Provide review and approval of design and execution of project deliverables based on schedule and associated plans. Advise on test requirements, scope, and acceptance criteria as per project deliverables as required
5. Support the site data integrity of associated computerized systems program 6. Advise on test requirements, scope, and acceptance criteria as per project deliverables.
7. As required based on project execution status Provide and monitor non-conformance results during the validation studies to determine acceptable remediation/corrective actions.
8.. Coordinate with other Quality stakeholders the development of associated shop floor practices linked to Quality Oversight of the intended process.
BSc/BEng plus previous experience in CQV field or equivalent combination of education and experience.
Experience in pharmaceutical/biopharmaceutical industry or related industry/manufacturing environment.
Areas of experience : plant utilities, clean utilities, HVAC, Filling lines, CTUs, component prep equipment, formulation.
Well-developed communication skills, both verbal and written. .
Years of Experience: 9 – 12 Years