LL01-012325 Project Manager – Biotech Manufacturing Projects - Validation & Engineering Group

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 build-outs, 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 end-to-end project execution for manufacturing-related 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 cross-functional teams, including Manufacturing, Quality Assurance, Engineering, Supply Chain, and Regulatory, to ensure alignment on project goals.
• Drive technology transfers and process scale-up 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:

• Bachelor’s 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 manufacturing-related projects, such as facility start-ups, 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 problem-solving 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.