Principal Project Manager - Engineering

We are looking for an experienced Project Engineer to join our growing Engineering team. Our Project Engineers design, specify and commission new and renovated biopharmaceutical process and clean utility equipment. We provide engineering support and lead deviation investigations for existing equipment and manufacturing processes to support the production of our life-changing medications.

As a Principal Project Manager - Engineering, a typical day might include the following:

• Designing and specifying cGMP process equipment, piping, and/or controls including development and review of engineering documentation
• Managing mid-to-large sized projects related to process equipment and clean utilities including start-up and commissioning
• Assisting in and leading the design review, site acceptance and installation of equipment
• Preparing piping and instrumentation diagrams and other related drawings
• Developing Process Flow Diagrams for manufacturing processes
• Supporting QA/Validation department by preparing design documents and assisting in protocol execution
• Assisting in investigations of process equipment, utility systems, and control system anomalies, as well as safety incidents
• Implementing corrective/preventative actions for existing equipment and manufacturing processes
• Preparing engineering evaluations and test plans for and executing modification change control documentation
• Supervising mechanical, electrical, and automation contractors
• Traveling up to 25% of the time, both domestically and internationally

This position might be for you if you:

• Have working knowledge of biopharmaceutical equipment, including filling, device assembly, label, and packaging equipment
• Are interested in having a broad scope with a variety of tasks, seeing the entire process, not just specific equipment or processes
• Enjoy solving puzzles and challenges, supporting investigations across the business
• Have a desire to contribute to elements of design work by helping to specify and translating customer needs into equipment
• Want to do more than just project management or troubleshooting, balancing your technical and project management skills
• Have a solid understanding of process control systems and automation
• Are skilled at planning and tracking project activities and schedules
• Are thoroughly knowledgeable with engineering documentation required for cGMP process equipment as well as sanitary equipment design requirements
• Have demonstrated strengths with strong interpersonal, cross-cultural communication
• Are adept at building and maintaining relationships and leading without direct authority
• Show resiliency and flexibility in the face of challenging situations

Qualified candidates must have a minimum of a Bachelor's degree in engineering, preferably Chemical Engineering or Biochemical Engineering and the following minimum years of experience in project/process engineering or an equivalent combination of advanced education and experience.

• Senior Project Engineer: 5+ years
• Principal Project Manager - Engineering: 8+ years

Direct experience with biopharmaceutical process equipment is preferred. Level will be determined based on qualifications relevant to the role.