Manufacturing Engineering Technician, 2nd shift

INCOG BioPharma is seeking a highly motivated individual with subject matter expert (SME) capabilities in sterile pharmaceutical manufacturing process and industrial mechanics. The Manufacturing Engineering Technician is a key technical role within INCOG BioPharma Manufacturing Engineering. 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 principals.

The Manufacturing Engineering Technician 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 should possess a strong mechanical aptitude and be able to adapt to the changing needs of a manufacturing environment while providing high level support to the process engineering, production engineering, inspection & packaging team, and the operations team in troubleshooting, repair and preventative maintenance of processing equipment. You will be expected to work hands-on, be actively involved in continuous process improvements while taking ownership of the equipment used in producing, inspecting, and packaging products. You will also be expected to demonstrate mentor and leadership skills to motivate personnel, drive timely production activities and inspire problem solving & solution driven thinking. Essential Job Functions:
SME for filling, formulation, inspection, packaging equipment, and supporting systems.
Perform duties in Grade C, D, and non-classified cleanrooms.
Perform aseptic manipulations within Grade A isolators.
Operate and support manufacturing processes; including changeovers, setup, and startup.
Perform preventative and corrective maintenance activities.
Resolve mechanical issues that arise in day-to-day running of Operations and providing timely responses and solutions.
Identify and implement solutions in collaboration with cross-functional technical teams and site leadership team.
Evaluate and improve efficiency of manufacturing, inspection, and packaging: instruments, equipment, and tools.
Enhance and apply new designs and processes that improve the functionality and reliability of manufacturing equipment.
Participate in FAT/SAT to better understand equipment and mechanical risks as a pre-requisite for process validation.
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. Special Job Requirements:
High School diploma required, AA/BS in biological sciences/biotechnology or related life-sciences field preferred.
5+ years of mechanical, electro-mechanical, installation, operation, or manufacturing maintenance experience required or 3+ years of similar direct experience in pharmaceutical/sterile manufacturing. Additional Preferences:
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.
Degree in engineering field.
Additional info about INCOG BioPharma Services:
At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business. If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus. 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. By submitting your resume and details, you are declaring that the information is correct and accurate.