Manufacturing Associate, 2nd shift
Description
INCOG BioPharma is seeking an individual with experience in sterile pharmaceutical manufacturing. The Manufacturing Associate is a key operational role within INCOG BioPharma Operations. The ideal candidate should have experience with pharmaceuticals and/or biologics equipment and processes, or GMP manufacturing.
The Manufacturing Associate’s primary responsibility is to efficiently and safely setup and operate the various pieces of production equipment within the clean room environment. They will be expected to accurately follow GMP documents (Batch records, SOPs, protocols, etc), work hands-on, and be actively involved in driving timely production activities to produce quality products. The ideal candidate should possess a mechanical aptitude with basic understanding and trouble shooting skills on manufacturing equipment. They should demonstrate the ability to work effectively in a team environment to achieve Company goals.
This is a second shift position.
Key responsibilities:
• Follow production and manufacturing procedures.
• Perform duties gowned in Grade C, D, and controlled non-classified cleanrooms.
• Perform aseptic manipulations within Grade A isolators.
• Perform cleaning/ sanitization, environmental monitoring, equipment preparation, bulk drug formulation, and aseptic filling duties as needed.
• Operate production equipment including setup and changeovers.
• Accurately document data and complete batch records.
• Execute validation/engineering protocols as needed.
• Prepare and stage all manufacturing materials needed for production.
• Collaborate and communicate with cross functional teams.
• Work flexible hours to ensure production facility coverage.
Minimum Education and Experience:
• High School diploma required
• 2+ years' experience in a GMP pharmaceutical manufacturing facility with the operation of manufacturing equipment
• Working knowledge of MS Office, MS Word, MS Excel, Windows or equivalent is required.
Additional Preferences:
• Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing (fill and finish) general Good Manufacturing Practices (cGMP)
• 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 SAP, MES, LIMS, SCADA.
Additional Information about INCOG BioPharma Services:
At INCOG BioPharma, we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.
If you crave the challenge of working for a high growth company and believe you have the intuition for a enhancing the business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma 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.
By submitting your resume and details, you are declaring that the information is correct and accurate.