Technical Project Manager

Your responsibilities

Project Scope and Strategy Development:

• Define the technical requirements and success criteria for the project, ensuring alignment with GMP standards, operational goals, and compliance expectations.
• Collaborate with stakeholders to integrate operational improvements into the overall project plan.
• Develop a comprehensive roadmap for the project lifecycle, from conceptual design through performance qualification (PQ).

Technical Leadership:

• Act as the primary technical point of contact for the project, ensuring all mechanical adaptations and operational improvements meet required specifications.
• Coordinate with EPCM teams to ensure alignment of engineering deliverables with technical and operational requirements.
• Provide guidance and support to production staff implementing operational improvements.

Quality and Compliance Oversight:

• Ensure that all project activities comply with GMP regulations and internal quality standards.
• Collaborate 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:

• Liaise with operations, maintenance, engineering, and quality teams to ensure seamless integration of mechanical adaptations into production.
• Facilitate communication and alignment between the production staff and the EPCM to address any technical challenges or deviations.

Project Execution and Monitoring:

• Monitor the progress of technical and operational activities to ensure milestones are met on time and within budget.
• Conduct risk assessments and develop mitigation plans for potential project roadblocks.
• 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 coordinate with validation teams to ensure the effectiveness and reliability of the implemented changes.

Your qualifications

• Degree in Biochemical Engineering, Mechanical Engineering, Life Sciences, or a related field.
• 5+ years of experience in biopharmaceutical manufacturing, with a strong focus on technical project management or operational excellence.
• Proven experience working on GMP-compliant projects, including change management and qualification activities.
• Hands-on experience in commissioning, qualification, and validation (CQV) of equipment and processes in a GMP environment.
• Strong knowledge of GMP regulations and biopharmaceutical manufacturing processes.
• Proficiency in project management tools and methodologies.