Manufacturing Specialist - Filling, 3rd shift

INCOG BioPharma Services•Fishers, IN

3d•Onsite

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 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. This is a 3rd shift position.

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.
Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing (fill and finish) general Good Manufacturing Practices (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.
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.