Production Engineer

Responsibilities:

• Troubleshoot and resolve issues that arise in daily operations, ensuring timely solutions and responses.
• Collaborate with cross-functional technical teams and site leadership to implement effective solutions.
• Serve as the Subject Matter Expert (SME) for filling equipment and supporting systems.
• Assess and enhance the efficiency of manufacturing instruments, equipment, and tools.
• Evaluate, recommend, and implement improvements and changes to existing processes.
• Contribute to or support Failure Modes and Effects Analysis (FMEA) to assess process and product risks, ensuring thorough preparation for process validation.
• Provide technical support to manufacturing operations.
• Apply Good Engineering Practices (GEP) to drive operational excellence and continuous improvement at the site.
• Work with vendors and suppliers to define technical requirements and understand functional specifications.

Qualifications:

• Bachelor's degree in engineering or life sciences, with a minimum of 5 years of relevant experience, or 10+ years of equivalent experience.
• Lean Six Sigma Certification.
• Strong practical knowledge of cGMP manufacturing processes and regulatory requirements for pharmaceuticals and medical devices.
• Proven expertise in pharmaceutical manufacturing, including biotechnology products, aseptic processing (fill and finish), and process development.

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