Job Title: Pharmaceutical Facility Manager
Manage the qualification and validation of pharmaceutical manufacturing facilities.
This role involves providing project management expertise to bring newly built facilities into commercial operation.
Responsibilities:
* Program Management: Oversee projects for facilities, equipment, utilities, computerized systems, alternate source qualifications.
* Qualification & Validation Management: Develop and implement strategies for facility, equipment, and utility qualification.
* Regulatory Compliance Oversight: Ensure facilities meet regulatory requirements and are ready for inspections.
* Cross-functional Coordination: Collaborate with engineering, validation, manufacturing, quality, and supply chain teams.
* Risk Management: Identify potential risks and develop mitigation strategies.
* Stakeholder Engagement: Act as primary point of contact for internal stakeholders.
* Budget Management: Monitor project budgets and optimize resource allocation.
* Operational Readiness: Develop plans for training, process validation, and initial production batches.
* Continuous Improvement: Identify and implement best practices in facility qualification and validation.
Requirements:
* Bachelor's or Master's degree in Engineering (Mechanical, Chemical, Biomedical, Industrial, or related field).
* PMP, Six Sigma Black Belt, Lean Manufacturing certification preferred.
* Strong understanding of GMP regulations and experience in regulatory audits.
* 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 problem-solving and critical thinking skills.
* Excellent communication, writing, presentation, and data organization skills.
* Demonstrated interpersonal and leadership qualities.