Duration:
6 months to start
Job Description
- The Process Engineer is responsible for large Custom Engineering projects, including engineering, procurement, manufacturing, testing, and delivery.
- The Senior Process Engineer is also responsible for assisting and training other team members, working on departmental projects, and supporting the development of new technologies.
- Lead full project lifecycle from pre-order sales support through final customer acceptance, ensuring alignment with standard work.
- Deliver all technical documentation and system components, including P&IDs, GAs, electrical/software packages, and turnover documentation.
- Communicate proactively with internal teams and customers, managing expectations and updates throughout the project.
- Drive performance outcomes by meeting KPIs (On-Time, Within Budget, Within Specification) and managing multiple complex or strategic projects.
- Troubleshoot system issues across mechanical, electrical, and automation domains during testing phases (Pre-FAT, FAT, SAT).
- Bachelor’s degree in engineering, management, or related field; graduate degrees in business or related field preferred
- 5+ years of previous experience in engineering or project management within the life sciences industry, with a focus on engineering disciplines (feasibility, design, construction, commissioning, and validation)
- Previous experience in performing equipment testing (FAT, SAT, commissioning, and qualification
- Well-developed communication skills, both verbal and written
- Ability to serve as the face of the client in stakeholder/customer-facing situations
- Experienced at compiling and following strict budgets
- Knowledge and understanding of the current industry guidelines for designing, manufacturing, testing and documenting biopharmaceutical process equipment. (ASME BPE, GAMP, cGMP, ISPE, etc.)
- Ability and willingness to work in a multinational and interdisciplinary team with a high degree of traveling.
- 5+ years of industrial experience (biotechnology and pharma) in engineering project management
- Practical application of pharmaceutical/biologics regulations.
- Experience managing both internal and vendor resources.
- Computer skills relating to general usage (Windows, Outlook, MS Office, etc.)
- Solution-driven with strong problem-solving and analytical skills
- Travel upwards 25% - international and domestic