Production Engineer

The Production Engineer is a key technical role within INCOG BioPharma Engineering and Technical Operations to ensure data integrity, implement state-of-the-art digital technologies, process control strategies, and support the technology road map. The ideal candidate must have experience in pharmaceuticals and/or biologics, GMP manufacturing, and/or within highly regulated industries as well as knowledge and experience in aseptic filling, sterile manufacturing, and engineering principles.

Essential Job Functions

Resolve issues that arise per daily operation and provide timely responses and solutions

Implement solutions in collaboration with cross-functional technical teams and site leadership

SME for filling equipment and supporting systems

Evaluate and improve efficiency of manufacturing instruments, equipment, and tools

Evaluate and implement new changes

Participate and/or support process FMEAs to understand process and product risks as a pre-requisite for process validation.

Provide technical support to manufacturing activities

Apply Good Engineering Practices (GEP) to drive site engineering and operational excellence.

Partner with vendors and suppliers to define requirements and understand functional specifications

Work flexible hours to ensure production facility coverage

Minimum Education and Experience

Bachelor’s degree in engineering field or life sciences with 5+ years of relevant work experience

Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing (fill and finish), and process development

Hands-on experience troubleshooting, repairing and performing preventative maintenance of manufacturing equipment

Additional Preferences

Lean Six Sigma Certification

Practical expertise with cGMP manufacturing and regulatory requirements for pharmaceuticals and devices

Applicable experience with process design, data integrity, controls, instrumentation, and electro-mechanical systems

INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.

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