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Bioprocess Project Lead
2 weeks ago
About the Role:
We are seeking a highly skilled Senior Bioprocess Project Manager to lead cross-functional teams in delivering complex processing equipment projects. Your primary focus will be on ensuring project success, managing stakeholder expectations, and driving process improvements.
Key Responsibilities:
- Lead teams of engineers, technicians, and vendors to design, procure, and install bioprocessing equipment.
- Develop and manage user requirement specifications (URS) and vendor selection processes.
- Generate request for capital expenditure (RCE) documents, place equipment orders, and conduct project management/design review meetings.
- Apply ASME BPE 2019 standards and relevant ISPE guidelines to ensure compliance.
- Oversee equipment installation, service hook-ups, and coordinate with vendors and site engineering teams.
- Conduct Factory Acceptance Testing (FAT) and manage documentation for equipment commissioning and qualification.
- Collaborate with stakeholders on training, operation and maintenance (O&M) manuals, spare parts lists, and preventive maintenance schedules.
- Participate in technical problem-solving forums related to product manufacturing and aseptic fill processes.
- Drive business improvement initiatives and contribute to cost reduction efforts.
Qualifications & Skills:
- Bachelor's degree in Engineering or equivalent experience.
- 5-10 years of experience in biologics, pharmaceutical, or medical device industries, with a proven track record in project management.
- Strong communication, interpersonal, and team leadership abilities.
- Self-starter with the ability to work independently and collaboratively across functions.
- Experience delivering project goals in a multidisciplinary environment.
