Manufacturing Specialist, 3rd Shift
Description
INCOG BioPharma 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 BioPharma 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 setup 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.
Key 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.
Minimum Requirements:
High School diploma and 3 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
Additional Preferences:
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