Technical Project Manager
A challenging opportunity is available for a technical project manager to lead biopharmaceutical projects from conceptual design through performance qualification.
Responsibilities:
* Project Scope and Strategy Development: Define technical requirements, success criteria, and 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.
* Technical Leadership: Act as primary technical point of contact for the project, ensuring mechanical adaptations meet required specifications.
* Coordinate with EPCM teams to ensure alignment of engineering deliverables.
* Provide guidance and support to production staff implementing operational improvements.
* Quality and Compliance Oversight: Ensure all project activities comply with GMP regulations and internal quality standards.
* Collaborate with QA teams to manage GMP change control processes.
* 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 production staff and EPCM to address technical challenges or deviations.
* Project Execution and Monitoring: Monitor progress of technical and operational activities to ensure milestones are met on time.
* Conduct risk assessments and develop mitigation plans for potential project roadblocks.
* Provide regular updates and technical reports to project stakeholders.
* Testing and Qualification: Lead planning and execution of equipment commissioning, installation qualification, operational qualification, and performance qualification activities.
* Oversee and coordinate with validation teams to ensure effectiveness and reliability of implemented changes.
Requirements:
* 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 of equipment and processes in a GMP environment.
* Strong knowledge of GMP regulations and biopharmaceutical manufacturing processes.
* Proficiency in project management tools and methodologies.