Equipment Specialist, 3rd shift

About the role

INCOG BioPharma is seeking a highly motivated Equipment Specialist with subject matter expert (SME) capabilities in sterile pharmaceutical manufacturing process controls and industrial automation. This key technical role supports INCOG BioPharma Operations, requiring experience in pharmaceuticals and/or biologics, GMP manufacturing, or highly regulated industries.

The Equipment Specialist will efficiently and safely set up and operate production equipment, drive continuous process improvements, and take ownership of product quality and quantity. The ideal candidate possesses strong mechanical aptitude, troubleshooting skills, and leadership abilities to mentor manufacturing personnel and inspire problem-solving.

This role requires adaptability to changing manufacturing needs while providing high-level support to process engineering and operations teams in troubleshooting, repair, and preventative maintenance of equipment and processes.

Responsibilities

• Follow production and manufacturing procedures.
• Perform duties in Grade C, 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 manufacturing tasks, including fill/finish, sanitization, component, and equipment preparation.
• Maintain production equipment and troubleshoot issues.
• Support equipment optimization and continuous improvement efforts.
• Resolve day-to-day operational issues with timely responses and solutions.
• Serve as SME for filling equipment and supporting systems.
• Participate in and/or support process FMEAs to assess process and product risks for validation.
• Provide technical support for manufacturing activities.
• Apply Good Engineering Practices (GEP) to drive site engineering and operational excellence.
• Work flexible hours to ensure production facility coverage.

Requirements

• High School diploma and 7 years of GMP pharmaceutical experience with installation, operation, cleaning, and maintenance of pharmaceutical GMP equipment.
• Working knowledge of MS Office (Word, Excel), Windows, or equivalent.

Qualifications

• BS in biological sciences/biotechnology and 1 year of GMP pharmaceutical experience with installation, operation, cleaning, and maintenance of pharmaceutical GMP equipment.
• Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing (fill and finish), and current 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 industry systems, including ERP and inventory management systems.

About INCOG BioPharma

INCOG BioPharma is a world-class CDMO specializing in parenteral injectable drugs. Our culture prioritizes long-term value for customers through a service-oriented mindset, technical excellence, and collaborative teamwork. We are based in Fishers, IN, and maintain a smoke-free campus.

Qualified applicants must be authorized to work in the United States on a full-time basis. INCOG will not provide sponsorship for work authorization or visas for this role.