The project manager will be responsible for leading capital projects for a growing BioPharma company. The role includes managing a diverse portfolio of strategic capital projects, such as equipment, productivity, and capacity upgrades, facility renovations, and infrastructure upgrades to support the commercial manufacturing of a rich pipeline of biologics products. The individual will have frequent exposure to senior management as they execute projects that shape our overall strategy and transform our site into a best-in-class BioPharma facility. Project execution will focus on safety, quality, schedule, and budget adherence in addition to complying with good engineering practices, company policies, regulations, and codes.
Provide project management services on a portfolio of capital and expense projects in a cGMP environment. Design and manage several facilities and process related capital projects (HVAC and utilities projects; biologics cell culture and purification upgrades; cryogenic storage capacity projects; laboratory and building infrastructure renovations; etc.) simultaneously to meet client's requirements. Provide technical support to Operations supporting the implementation of new technology in the areas of biologics cell culture, protein purification, use of disposables, automation, and PAT. Coordinate projects with site Maintenance, Calibration, Validation, Automation, and Facilities departments from project initiation to closure to ensure all systems are designed, constructed, and documented properly. Provide recommendations to improve and maintain facilities infrastructure.
- Ability to safely manage projects on schedule and within budget using contractors and/or internal technicians.
- Experience using Microsoft Project as a project planning and tracking tool to successfully manage projects.
- Ability to scope projects based upon client's requirements, obtain budget estimates, write capital appropriation requests, develop project schedules, and manage a cross-functional project team in a matrix organization.
- Strong analytical skills and logical troubleshooting skills are required.
- Understanding of regulatory, environmental, cGMP/GLP and OSHA regulations is preferred.
- Knowledge of laboratory, manufacturing facilities, utilities and infrastructure, construction, maintenance, and operations is preferred.
- B.S Degree in Engineering or related discipline is required.
- Project Management Professional certification is preferred.
- 3-5 years or more of relevant engineering and project management experience is preferred.
- Experience working in a biologics or pharmaceutical environment is preferred.
Physical demands of the job include unassisted lifting of items, not to exceed 50 lbs; crouching/squatting; kneeling; sitting; crawling; walking on level surfaces; climbing stairs and ladders; and vision (visual inspection of installations). The job will also require the use of PPE, such as hard hat, hearing protection, safety glasses, steeled toed shoes, and fall protection.