LL01-012325 Project Manager Biotech Manufacturing Projects
LL01-012325 Project Manager Biotech Manufacturing Projects
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Job Description
Validation & Engineering Group Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical Biotechnology Chemical Food and Medical Devices industries in the following areas: Laboratory Compliance Computer Engineering Project Management Validation and other services.
We are seeking a talented dedicated individual committed to work under the highest ethics standards for the following position:
- Project Manager Biotech Manufacturing Projects
We are seeking a skilled and motivated Project Manager for Biotech Manufacturing Projects to lead complex manufacturing initiatives within our organization. This role involves planning coordinating and executing projects focused on manufacturing operations including facility buildouts technology transfers process improvements and scaling production capabilities. The ideal candidate will have a deep understanding of biotech manufacturing processes regulatory requirements and project management best practices.
Key Responsibilities:
1. Project Management and Planning:
- Oversee endtoend project for manufacturingrelated initiatives including facility expansions new production line installations and process optimization.
- Develop project plans including scope timelines milestones budgets and risk assessments.
- Monitor project progress and ensure timely delivery of key deliverables.
2. Manufacturing Operations Coordination:
- Collaborate with crossfunctional teams including Manufacturing Quality Assurance Engineering Supply Chain and Regulatory to ensure alignment on project goals.
- Drive technology transfers and process scaleup efforts for new products or production lines.
- Coordinate commissioning qualification and validation (CQV) of manufacturing systems and equipment.
3. Regulatory Compliance and Quality:
- Ensure projects adhere to regulatory requirements including GMP FDA EMA and other applicable standards.
- Work closely with Quality Assurance to integrate compliance into all aspects of manufacturing projects.
- Prepare for and support regulatory inspections or audits as required.
4. Risk and Resource Management:
- Identify potential risks and develop mitigation strategies to ensure project success.
- Manage project budgets control costs and allocate resources efficiently.
- Balance multiple projects ensuring resource availability and prioritization.
5. Stakeholder Communication:
- Act as the main point of contact for project updates ensuring transparent and timely communication with internal teams leadership and external partners.
- Prepare and present project status reports to senior management including performance metrics risk assessments and recommendations.
6. Continuous Improvement:
- Identify and implement process improvements to enhance manufacturing efficiency scalability and quality.
- Stay current with emerging manufacturing technologies and industry best practices to recommend innovative solutions.
Qualifications:
Education:
- Bachelors degree in engineering life sciences or a related field.
- Advanced degree (MBA MS or Ph.D. preferred.
Experience:
- 5 years of project management experience in biotech pharmaceutical or life sciences manufacturing.
- Proven track record of managing manufacturingrelated projects such as facility startups technology transfers or process optimizations.
Skills:
- Strong knowledge of GMP FDA and EMA regulatory requirements.
- Proficiency in project management tools (e.g. MS Project Smartsheet or equivalent).
- Exceptional leadership communication and problemsolving abilities.
- Familiarity with Lean Manufacturing Six Sigma or other operational excellence methodologies.
- Certifications (Preferred):
- PMP (Project Management Professional) certification.
- Lean Six Sigma certification or equivalent.
Required Experience:
IC
Employment Type
Contract
