Equipment Specialist

About the role

INCOG BioPharma is seeking a highly motivated Manufacturing Specialist with subject matter expert (SME) capabilities in sterile pharmaceutical manufacturing process controls and industrial automation. This key technical role supports operations in a GMP manufacturing environment, focusing on parenteral injectable drugs.

Responsibilities

• Follow production and manufacturing procedures in Grade C, D, and controlled non-classified cleanrooms.
• Perform aseptic manipulations within Grade A isolators.
• Conduct cleaning, sanitization, equipment preparation, and aseptic filling duties.
• Safely operate production equipment, including setup and changeovers.
• Accurately document data and complete batch records.
• Execute validation and engineering protocols as needed.
• Train others in manufacturing tasks such as fill/finish, sanitization, component, and equipment preparation.
• Maintain production equipment and troubleshoot issues.
• Support equipment optimization and continuous improvement efforts.
• Collaborate and communicate with cross-functional teams.
• Work flexible hours to ensure production facility coverage.

Requirements

• High School diploma and 3 years of GMP pharmaceutical experience with the operation, cleaning, and maintenance of pharmaceutical filling equipment.
• Working knowledge of MS Office (Word, Excel) and Windows.
• Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing (fill and finish), and current Good Manufacturing Practices (cGMP).

Qualifications

• BS in biological sciences/biotechnology and 1 year of GMP pharmaceutical experience with the installation, operation, cleaning, and maintenance of pharmaceutical GMP equipment (preferred).
• 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 committed to quality outcomes and accelerating our customers' route to market. All positions are based in Fishers, IN, and our campus is smoke-free.