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Equipment Specialist Summary

INCOG BioPharma is seeking a highly motivated individual with subject matter expert (SME) capabilities in sterile pharmaceutical manufacturing process controls and industrial automation. The Equipment Specialist has a key technical role within INCOG BioPharma Operations. The ideal candidate must have experience in pharmaceuticals and/or biologics, GMP manufacturing, or within highly regulated industries.

The Equipment Specialist's primary responsibility is to efficiently and safely set up and operate various pieces of production equipment within the facility. They 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. The ideal candidate should possess a strong mechanical aptitude with strong trouble shooting skills on manufacturing equipment. They should demonstrate mentor and leadership skills to motivate manufacturing personnel, drive timely production activities and inspire problem solving & solution driven thinking.

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.

Essential Job Functions:

• Follow production and manufacturing procedures.

• Perform duties in Grade D and controlled non-classified cleanrooms.

• Perform aseptic manipulations within Grade A isolators.

• Safely operate production equipment including setup and changeovers.

• Lead batch start up activities and execution of production cycles

• Accurately document data and complete batch records.

• Execute validation/engineering protocols as needed.

• Train others in various manufacturing tasks including, but not limited to inspection/packaging operations, sanitization, component and equipment preparation.

• Maintain production equipment and troubleshoot issues.

• Support equipment optimization efforts and continuous improvement efforts.

• Resolve issues that arise in day to day running of operation and providing timely responses and solutions.

• SME for Inspection and Packaging equipment and supporting systems.

• 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.

• Work flexible hours to ensure production facility coverage.

Special Job Requirements:

• High School diploma and 7 years of GMP pharmaceutical experience with the installation, operation, cleaning, and maintenance of pharmaceutical GMP equipment.

• Working knowledge of MS Office, MS Word, MS Excel, Windows or equivalent is required.

• Functional knowledge of industry guidance and requirements applicable to visual inspection, including USP <790> and <1790>; FDA Draft Guidance: Inspection of Injectable Products for Visible Particulates (2021); PDA Technical Reports, and European Pharmacopoeia 2.9.20: Particulate Contamination: Visible Particles.

• Awareness of industry trends, including FDA actions, in manual and automated inspection processes.

• SME on Knapp-Abramson Analysis Framework, individual certification for manual visual inspection, defect kit creation, qualification, and control; and qualification strategies for SASI and AIM.

Additional Preferences:

• BS in biological sciences/biotechnology and 1 year of GMP pharmaceutical experience preferred.

• Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing (fill and finish) general Good Manufacturing Practices (cGMP).

• Excellent communication skills.

• Ability to apply concepts such as fractions, percentages, ratios and proportions to practical situations.

• Ability to learn and operate a range of industry systems including and not limited to ERP and inventory management systems.

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.

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