Production Engineer

Job Responsibilities:

· Troubleshoot and resolve daily operational issues with prompt and effective solutions.

· Collaborate with cross-functional technical teams and site leadership to implement improvements.

· Serve as the Subject Matter Expert (SME) for filling equipment and supporting systems.

· Analyze and enhance the performance of manufacturing equipment, instruments, and tools.

· Assess, recommend, and implement operational changes for continuous improvement.

· Participate in and support FMEAs to identify and mitigate process and product risks.

· Provide technical guidance for manufacturing operations while maintaining compliance with Good Engineering Practices (GEP).

· Partner with vendors to define requirements and validate functional specifications.

· Maintain flexibility to ensure adequate production facility coverage.

Qualifications:

· Bachelor’s degree in engineering or life sciences with 5+ years of relevant experience; or 10+ years of equivalent work experience.

· Lean Six Sigma Certification preferred.

· Strong knowledge of cGMP manufacturing processes and regulatory requirements for pharmaceuticals and medical devices.

· Practical expertise in biotechnology product manufacturing, aseptic processing (fill and finish), and process development.