Manufacturing Specialist - Filling
About The Position
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 is a key technical role within INCOG BioPharma Operations, requiring 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 are expected to work hands-on, be actively involved in continuous process improvements, and take ownership of the quality and quantity of product produced. The ideal candidate should possess a strong mechanical aptitude with strong troubleshooting skills on manufacturing equipment. They should also demonstrate mentor and leadership skills to motivate manufacturing personnel, drive timely production activities, and inspire problem-solving and solution-driven thinking.
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, MS Word, MS Excel, Windows or equivalent is required.
Nice To Haves
- 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.
Responsibilities
- Follow production and manufacturing procedures.
- Perform duties in Grade C, D, and controlled non-classified cleanrooms.
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
Number of Employees
101-250 employees
