Job description:

We are seeking a Technical Project Manager to lead capital investment projects in a GMP-regulated mammalian cell production line, driving initiatives from design to qualification.

About the customer:

The client is a leader in the Pharmaceutical industry, renowned for its innovative solutions and commitment to quality in healthcare.

Requirements:

Project Scope and Strategy Development:

• Define project requirements, align with GMP standards, and integrate operational improvements.
• Develop a roadmap covering design through performance qualification (PQ).

Technical Leadership:

• Act as the primary technical contact, ensuring specifications are met.
• Coordinate with EPCM teams and support production staff in operational improvements.

Quality and Compliance Oversight:

• Ensure compliance with GMP regulations and manage change control processes with QA teams.

Cross-Functional Coordination:

• Collaborate with operations, maintenance, engineering, and quality teams to integrate mechanical adaptations and resolve challenges.

Project Execution and Monitoring:

• Track progress, address risks, and deliver regular updates to stakeholders.

Testing and Qualification:

• Lead commissioning, installation (IQ), operational (OQ), and performance qualification (PQ) activities.

Competences:

Education:

• Bachelor's or Master's degree in Biochemical Engineering, Mechanical Engineering, Life Sciences, or a related field.

Experience:

• Minimum of 5 years' experience in biopharmaceutical manufacturing, with a focus on technical project management or operational excellence.
• Proven track record in GMP-compliant projects, including change management and qualification activities.
• Hands-on experience in commissioning, qualification, and validation (CQV) of equipment and processes.

Skills:

• Strong knowledge of GMP regulations and biopharmaceutical manufacturing processes.
• Proficiency in project management tools and methodologies.
• Excellent problem-solving skills to manage technical challenges in a fast-paced environment.
• Effective communication and interpersonal skills for coordinating cross-functional teams.
• Detail-oriented with strong organizational skills for managing multiple workstreams

Compensation benefits:

• Opportunity to contribute to impactful projects within a leading biopharmaceutical organization.
• A collaborative and innovative work environment.
• Professional growth and development opportunities.