Senior Engineering Project Manager
We are seeking a seasoned project professional to oversee the transition from detailed design to construction and qualification of mechanical adaptations within an existing GMP commercial mammalian production line.
* Maintaining design intent throughout all phases is crucial for project success.
* Reviewing and approving technical documents, drawings, and equipment specifications ensures quality and constructability.
* Monitoring and controlling scope, schedule, cost, and risk is essential in managing project resources effectively.
* Facilitating coordination between EPCM, internal engineering teams, quality assurance, and operations is vital for successful project delivery.
* Ensuring alignment with design and construction sequencing through procurement activities is critical.
* Adhering to GMP regulations and company policies is mandatory throughout the project lifecycle.
* Collaborating with quality assurance teams to ensure deliverables meet regulatory requirements is key.
* Maintaining comprehensive documentation, including risk assessments, design reviews, and performance qualification records, is necessary for transparency and accountability.
* Effective resource management and budget development are crucial for successful project execution.
* Overseeing performance qualification activities and collaborating with production staff during validation ensures seamless handover.
To be successful in this role, you will require a Bachelor's degree in Engineering and 5-7 years of experience in project management within a biopharmaceutical or regulated manufacturing environment.