Manufacturing Specialist - Filling, 2nd shift

Manufacturing Specialist – Filling Summary

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

The Manufacturing 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.

• Follow production and manufacturing procedures.
• Perform duties in Grade C, D, and controlled non‑classified clean rooms.
• Perform aseptic manipulations within Grade A isolators.
• Perform cleaning and sanitization, equipment preparation, and aseptic filling duties as needed.
• Safely operate production equipment including setup and changeovers.
• Accurately document data and complete batch records.
• Execute validation/engineering protocols as needed.
• Train others in various manufacturing tasks including, but not limited to: fill/finish, sanitization, component and equipment preparation.
• Maintain production equipment and troubleshoot issues.
• Support equipment optimization efforts and continuous improvement efforts.
• Collaborate and communicate with cross functional teams.
• Work flexible hours to ensure production facility coverage.

• 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, MS Word, MS Excel, Windows or equivalent is required.

• BS in biological sciences/biotechnology and 1 year of GMP pharmaceutical experience with the installation, operation, cleaning, and maintenance of pharmaceutical GMP equipment.
• 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.

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.