Website Asset Recruitment
QA Validation Engineer
This position provides senior level support to the QA Validation function
Provide quality oversight of facility and equipment commissioning and qualification activities.
- Provide technical assessments on management of change, deviations and investigations, assessing proposed changes to validated processes to identify requirements necessary to maintain validated status.
- Provide quality oversight of engineering and validation studies, and review and approval of protocols and summary reports.
- Use project management skills to drive results and achieve expected timelines and outcomes.
- Represent the QA team on project core teams and participate in strategy discussions aligned with global initiatives and regulatory requirements.
- Support regulatory inspections and inspection readiness activities.
- Provide quality oversight and ensure GMP compliance for engineering and validation deliverables related to site projects (Compliance, Improvement, etc.)
- Provide QA reviews for definition, specification, engineering design, qualification, cleaning and manufacturing process validation, and change management.
- Serve as point of contact for client/PM to identify project needs and ensure practices are consistent with quality and regulatory standards.
- Support site continuous improvement initiatives
- 5+ years of industry experience in a pharmaceutical GMP environment.
- BS in Engineering and / or Science
- Minimum 3 years project support experience with increasing responsibility in the areas of Quality Assurance.
- Knowledge of FDA and EMA regulations and a working knowledge of statistical analysis and root cause analysis is required.
- Excellent interpersonal skills and strong oral and written communication.