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Pharmaceutical Facility Manager
2 weeks ago
Job Title: Pharmaceutical Facility Manager
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- We are seeking an experienced Program Manager to oversee the qualification and validation of our pharmaceutical manufacturing facilities.
Description:
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- The successful candidate will be responsible for managing projects that bring newly built facilities into commercial operation, ensuring compliance with GMP regulations and regulatory expectations.">
- This includes providing a project management approach for facility, equipment, and utility qualification (IQ/OQ/PQ), as well as coordinating efforts across Engineering, Validation, Manufacturing, Quality, and Supply Chain teams.">
- The Program Manager will also ensure facility readiness for regulatory inspections and approvals, monitor project budgets, and optimize resource allocation.">
- Additionally, they will develop and execute plans for training, process validation, and initial production batches to ensure the facility is prepared for GMP operations.">
- Strong problem-solving and critical thinking skills are essential, along with excellent communication, writing, presentation, and data organization abilities.">
Requirements:
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- Bachelor's or Master's in Engineering (Mechanical, Chemical, Biomedical, Industrial, or related field) or equivalent experience.">
- PMP, Six Sigma Black Belt, Lean Manufacturing certification preferred.">
- Minimum 5-8 years of experience in pharmaceutical facility qualification, validation, or technical operations.">
- Demonstrated ability to plan, design, and manage significant NPI and Tech Transfer projects.">
- Strong understanding of Annex I, US, and EMA GMP regulations.">
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