Production Engineer- IDAP, 2nd Shift or 3rd Shift

Overview

The Production Engineer is a key technical role within INCOG Bio Pharma 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 packaging automation, manufacturing, and engineering principles.

The Production Engineer will have the demonstrated ability to apply experience to process design, design thinking, data integrity, controls, instrumentation, and electro‑mechanical systems. This position will partner and lead internal operations continuous improvement initiatives.

The ideal candidate must thoroughly understand and be able to adapt to the changing needs of a manufacturing environment while providing high‑level support to the process engineering and operations team in troubleshooting, repair and preventative maintenance of manufacturing equipment and processes. You will be expected to work hands‑on, be actively involved in continuous process improvements while taking ownership of the quality and quantity of product produced.

You will also be expected to demonstrate mentor and leadership skills to motivate manufacturing personnel, drive timely production activities and inspire problem‑solving & solution‑driven thinking. Additionally, this position would act as the owner of the equipment tracking process for manufacturing equipment.

This is an off‑shift position

Second Shift (3:00‑11:30 pm) or Third Shift (11:00 pm‑7:30 am) based on preference

• Resolve issues that arise in day‑to‑day running of operation and providing timely responses and solutions
• Implement solutions in collaboration with cross‑functional technical teams and site leadership team
• SME for automated packaging/inspection 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

• Bachelor’s degree in engineering field, or life sciences with 5+ years of relevant work experience
• Or 10+ 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

INCOG Bio Pharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG Bio Pharma 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.

Qualified applicants must be authorized to work in the United States on a full‑time basis. INCOG will not provide support for or sponsor work authorization or visas for this role, including but not limited to F‑1 CPT, F‑1 OPT, F‑1 STEM OPT, J‑1, H‑1B, TN, O‑1, E‑3, H‑1B1, or L‑1.

By submitting your resume and details, you are declaring that the information is correct and accurate.