Capital Project Manager (cGMP - Pharmaceutical) JD817697
Boston, MA area
DPS Engineering is looking for a proven Project Manager/Engineer to work with a BioPharma client in the Boston, MA area. This individual will be responsible for the planning and delivery of the project scope by managing a team of internal and external resources; tracking project performance against established targets (cost and schedule); monitoring, controlling and reporting on project status including risks and issues; and ensuring the successful return of the facility, equipment and/or system(s) to routine operations.
- Project implementation - Oversee all design, procurement, development, fabrication, installation, and testing of all systems and equipment as specified and in accordance with all project requirements.
- Must have construction project experience; laboratory and/or office fit-out knowledge is preferred.
- Will be expected to process submittals, review construction progress in the field, and interact with the A/E and Construction Management resources.
- Develop cost and manpower estimates as well as implementation timelines.
- Project initiation - Work with project sponsors and solution providers to identify business drivers, project objectives, and project requirements.
- Must be able to consult and coordinate effectively with external contacts including A&E firms, construction or procurement vendors, CQV contractors, and other regulatory agencies.
- Oversee the preparation and hand-over to end users to enable successful operation of newly installed or modified systems and equipment.
Qualifications and Education:
- Bachelor's degree in Chemical, Mechanical or other related Engineering or relevant field.
- Requires a minimum of 8+ years of project management experience in engineering, construction or owner organization and a minimum of 5+ years related experience in Biopharmaceutical, Pharmaceutical or High Technology facility design and construction.
- Strong knowledge of biotech processing manufacturing, facility design, process and control systems is required.
- Expert knowledge of Project Management methodologies and life cycle including ISPE good practice is required.
- Strong understanding of industrial and cGMP requirements, Engineering Life Cycle, and associated quality systems.
- Experience facilitating meetings and establishing safe practices in a cGMP environment.