Production Engineer

Job Responsibilities:

• Address day-to-day operational issues by providing timely responses and solutions.
• Collaborate with cross-functional technical teams and site leadership to implement solutions.
• Serve as a subject matter expert (SME) for filling equipment and supporting systems.
• Assess and enhance the efficiency of manufacturing instruments, equipment, and tools.
• Participate in and support process FMEAs to identify process and product risks prior to validation.
• Offer technical support for manufacturing activities.
• Utilize Good Engineering Practices (GEP) to promote engineering and operational excellence at the site.
• Collaborate with vendors and suppliers to establish requirements and understand functional specifications.

Qualifications:

• Bachelor’s degree in engineering field, or life sciences with 5+ years of relevant work experience.
• Lean Six Sigma Certification.
• Practical expertise with cGMP manufacturing and regulatory requirements for pharmaceuticals and devices.
• Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing (fill and finish), and process development.