Production Engineer

Job Responsibilities:

• Address operational issues and provide prompt solutions to ensure smooth day-to-day operations.
• Collaborate with cross-functional technical teams and site leadership to implement effective solutions.
• Serve as a Subject Matter Expert (SME) for filling equipment and related support systems.
• Assess and enhance the efficiency of manufacturing instruments, equipment, and tools.
• Evaluate and apply necessary changes to improve processes.
• Contribute to or assist with process FMEAs to assess process and product risks as part of the process validation.
• Provide technical support for manufacturing activities.
• Apply Good Engineering Practices (GEP) to promote engineering and operational excellence on-site.
• Collaborate with vendors and suppliers to define requirements and understand functional specifications.
• Work flexible hours to ensure continuous coverage at the production facility.

Qualifications:

• Bachelor’s degree in an engineering discipline or life sciences, with 5+ years of relevant experience.
• Alternatively, 10+ years of relevant professional experience.
• Lean Six Sigma Certification.
• In-depth experience with cGMP manufacturing and regulatory requirements for pharmaceuticals and medical devices.
• Strong knowledge of pharmaceutical manufacturing for biotechnology products, aseptic processing (fill and finish), and process development.