In this role, the Technical Project Manager will be instrumental in ensuring the successful execution of capital investment initiatives within a commercial mammalian cell production environment. This position requires a combination of technical knowledge, operational efficiency, and project management skills to guarantee that the investments achieve the desired mechanical modifications and operational enhancements. The Technical Project Manager will serve as the main point of contact among operational teams, quality assurance, and the Engineering team responsible for overseeing the Engineering, Procurement, and Construction Management (EPCM) contractor.

Project Duration: Approx. 6 Months

Starting Date: ASAP

Key Responsibilities

Project Scope & Strategy Development

  • Establish the technical specifications and success criteria for projects, ensuring they align with GMP standards, operational objectives, and compliance requirements
  • Collaborate with stakeholders to incorporate operational enhancements into the project plan
  • Create a detailed roadmap for the project lifecycle, from initial design through performance qualification

Technical Leadership

  • Serve as the primary technical representative for projects, ensuring mechanical modifications and operational enhancements adhere to required specifications
  • Coordinate with EPCM teams to align engineering deliverables with technical and operational needs
  • Offer guidance and support to production personnel in implementing operational improvements

Quality and Compliance Oversight

  • Ensure that all project activities adhere to GMP regulations and internal quality standards
  • Work with QA teams to manage GMP change control processes, including the preparation, review, and approval of Technical Change Requests (TCRs) and Change Records (CRs)

Cross-Functional Coordination

  • Communicate with operations, maintenance, engineering, and quality teams to ensure seamless integration of mechanical modifications into production
  • Facilitate communication and alignment between production staff and the EPCM to resolve any technical issues or deviations

Project Execution and Monitoring

  • Track the progress of technical and operational activities to guarantee milestones are achieved on schedule and within budget
  • Perform risk assessments and develop mitigation strategies for potential project obstacles
  • Provide regular updates and technical reports to project stakeholders

Testing and Qualification

  • Lead the planning and execution of equipment commissioning, installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities
  • Oversee and collaborate with validation teams to ensure the effectiveness and reliability of implemented changes

Candidate Profile

Education

  • Bachelor’s or Master’s degree in Biochemical Engineering, Mechanical Engineering, Life Sciences, or a related discipline

Experience

  • Over 5 years of experience in biopharmaceutical manufacturing, focusing on technical project management or operational excellence
  • Demonstrated experience in GMP-compliant projects, including change management and qualification activities
  • Practical experience in commissioning, qualification, and validation (CQV) of equipment and processes in a GMP environment

Skills

  • Strong understanding of GMP regulations and biopharmaceutical manufacturing processes
  • Proficient in project management tools and methodologies
  • Excellent problem-solving abilities with the capacity to navigate technical challenges in a fast-paced setting
  • Strong communication and interpersonal skills to effectively coordinate cross-functional teams
  • Detail-oriented with exceptional organizational skills for managing multiple workstreams

 

Job ID 41180393