Process Engineer - Masis Professional Group : Job Details

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.