Production Engineer

Job Title: Production Engineer

Job Overview:

Our organization, a leader in contract manufacturing for pharmaceuticals and biologics, is seeking an experienced Production Engineer to support technical operations and drive excellence in GMP manufacturing. This key role focuses on ensuring data integrity, implementing advanced digital technologies, and supporting process control strategies to enhance production efficiency. The ideal candidate will leverage expertise in aseptic filling, sterile manufacturing, and engineering principles to troubleshoot issues, optimize equipment, and support robust manufacturing processes.

Job Responsibilities:

• Address and resolve operational issues in real-time, providing timely and effective solutions.
• Collaborate with cross-functional technical teams and leadership to implement process improvements.
• Serve as a subject matter expert (SME) for filling equipment and related systems.
• Assess and enhance the efficiency of manufacturing instruments, equipment, and tools.
• Evaluate and implement process changes to improve production reliability and compliance.
• Participate in process Failure Mode and Effects Analysis (FMEA) to identify risks and support process validation.
• Provide technical expertise to support manufacturing activities and ensure operational continuity.
• Apply Good Engineering Practices (GEP) to drive engineering and operational excellence across the site.
• Work with vendors and suppliers to define requirements and understand functional specifications for equipment and systems.
• Support flexible scheduling to ensure production facility coverage, particularly for 3rd shift operations.

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or a related field required, with 5+ years of relevant experience in pharmaceutical or biologics manufacturing.
• Demonstrated expertise in pharmaceutical manufacturing, including aseptic processing (fill and finish) and process development.
• Hands-on experience troubleshooting, repairing, and performing preventive maintenance on manufacturing equipment.
• Strong knowledge of cGMP manufacturing and regulatory requirements for pharmaceuticals and medical devices.
• Proven ability to collaborate with cross-functional teams and communicate technical solutions effectively.

Additional Preferences:

• Lean Six Sigma certification or equivalent experience in process optimization.
• Practical experience with process design, data integrity, controls, instrumentation, and electro-mechanical systems.
• Familiarity with regulatory requirements for pharmaceuticals and medical devices in GMP environments.