Process Engineer

Our client is a Contract Manufacturing site (CMO) that specializes in the manufacturing of radiopharmaceuticals . The cGMP clean room suites are 21 CFR 211 compliant. The facility is dedicated to late stage investigational and commercial stage radiopharmaceuticals . Due to growth, they are looking to add a Process Engineer to join their expanding team!

The company offers a very competitive compensation and 100% paid medical and dental, extremely generous 401k match, bonus, and other phenomenal benefits!

Job Summary: This position provides engineering support for design, build and maintenance of manufacturing suites (radiochemical and GMP), equipment and facility support systems. Provides technical support to Production.

Process Engineer Key Responsibilities:

• Coordination and implementation of all activities relating to troubleshooting, maintenance and repair, production projects and measuring equipment.
• Spare parts, wear parts and measuring equipment management.
• Continuous improvement- identification of optimization potential and implementation of own ‘small optimizations' as well as production-side support in the process optimization of development projects.
• Lead or participate in investigations to drive technically and scientifically sound corrective and preventative actions. Apply creative problem-solving techniques using knowledge base and historical experience to address immediate, short-term and future needs. Lead root-cause analysis investigations as a technical resource.
• Ensuring the implementation of corrective measures in the event of process and quality deviations in collaboration with quality assurance and development.
• Interact with contract organizations, suppliers and vendors.
• Actively promote safety rules and awareness. Demonstrate good safety practices at all times including the appropriate use of protective equipment. Report and take initiative to correct safety & environmental hazards.

Process Engineer Key Qualifications:

• BS degree in Chemical engineering preferred but will consider other Engineering degrees.
• 3-5 years' experience as a Process Engineer with design experience .
• Design experience using AutoCAD is highly preferred but may consider other design programs.
• Confident handling of IT applications such as MS Office Suite.
• Practical experience in plant construction or in the technical supervision of experimental set-ups, possibly also as part of an internship or scientific collaboration at a university.
• Knowledge of quality management and/or quality assurance.
• Creation and modification of technical drawings, floor plans, equipment documentation as well as support in the preparation of qualification plans and other regulated documents.
• Experience in a GMP manufacturing environment.
• Willingness to travel on business at home and abroad.