Job Title: Program Manager for Pharmaceutical Facility Operations
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As a Program Manager for Pharmaceutical Facility Operations, you will be responsible for providing project management expertise to ensure the successful qualification and validation of pharmaceutical manufacturing facilities. Your primary focus will be on managing the qualification and validation activities necessary to bring new facilities into commercial operation.
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Key Responsibilities:
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1. Provide project management approach and implementation for managing qualification and validation activities.
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2. Manage facility, equipment, and utility qualification (IQ/OQ/PQ) in accordance with GMP and regulatory expectations.
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3. Ensure facility readiness for regulatory inspections and approvals, including FDA and EMA requirements.
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4. Coordinate efforts across Engineering, Validation, Manufacturing, Quality, and Supply Chain teams to ensure seamless transition into commercial operations.
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5. Identify potential qualification and validation risks and develop mitigation strategies to keep projects on track.
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6. Act as primary point of contact for internal stakeholders.
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7. Monitor project budgets and optimize resource allocation to ensure cost-effective execution of programs.
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Requirements:
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* Bachelor's or Master's degree in Engineering (Mechanical, Chemical, Biomedical, Industrial, or related field).
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* PMP, Six Sigma Black Belt, Lean Manufacturing certification preferred.
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* Strong understanding of Annex I, US, and EMA GMP regulations, with practical experience in regulatory audits.
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* Minimum 5-8 years of experience in pharmaceutical facility qualification, validation, or technical operations.
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* Demonstrated ability to plan, design, and manage significant NPI and Tech Transfer projects.
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* Strong problem-solving and critical thinking skills.
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* Excellent communication, writing, presentation, and data organization skills.
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* Demonstrated interpersonal and leadership qualities.
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What We Offer:
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Our company specializes in recruitment of management and technical professionals for various industries. We operate from multiple locations in Ireland and have offices in several major cities.
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Skills: Program Manager Qualification Validation
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