Aseptic Equipment Specialist
About The Position
INCOG BioPharma is seeking a highly motivated individual with subject matter expert (SME) capabilities in sterile pharmaceutical manufacturing process controls and industrial automation. The Equipment Specialist is a key technical role within INCOG BioPharma Operations. This candidate must have experience in pharmaceuticals and/or biologics, GMP manufacturing, or within highly regulated industries. The Equipment 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.
Requirements
- High School diploma and 7 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.
- Must have previous experience with pharmaceutical aseptic processing (fill and finish) cGMP.
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.
- 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.
- 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 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.
- Resolve issues that arise in day to day running of operation and providing timely responses and solutions.
- SME for filling equipment and supporting systems.
- Participate and/or support process FMEAs to understand process and product risks as a pre-requisite for process validation.
- Provide technical support to manufacturing activities.
- Apply Good Engineering Practices (GEP) to drive site engineering and operational excellence.
- 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
