Principal Project Engineer

Role Summary

We are looking for an experienced Engineer to join our growing Project Engineering team. Our team designs, specifies and commissions 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.

Responsibilities

• Designing and specifying cGMP process equipment, piping, and/or controls including development and review of engineering documentation
• Managing mid-sized to large projects related to process equipment and clean utilities including start-up and commissioning
• 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 and engineering contractors
• Traveling up to 10% of the time, both domestically and internationally

Qualifications

• Required: Bachelor's degree in Chemical Engineering or Biochemical Engineering (or another relevant Engineering discipline)
• Required: 8+ years of experience in project/process engineering for Principal Project Engineer
• Preferred: Direct experience with biopharmaceutical process equipment

Skills

• Ability to work with a broad scope and view the entire process, not just specific equipment or processes
• Strong problem-solving skills and ability to support investigations across the business
• Ability to translate customer needs into equipment specifications
• Balance of technical and project management skills
• Solid understanding of process control systems and automation
• Strong planning and scheduling capabilities
• Thorough knowledge of engineering documentation required for cGMP process equipment and sanitary equipment design
• Working knowledge of biopharmaceutical equipment
• Strong interpersonal and cross-cultural communication
• Ability to build and maintain relationships and lead without direct authority
• Resiliency and flexibility in challenging situations

Education

• Bachelor's degree in Chemical Engineering or Biochemical Engineering (or another relevant Engineering discipline)

Additional Requirements

• Travel up to 10% domestically and internationally