Parenteral Manufacturing Associate

Cook Pharmica is a contract manufacturer of biopharmaceutical products for both clinical and commercial use. With our extensive service portfolio, and the addition of parenteral manufacturing in 2010, we will be a one-source solution for clients’ needs from cell line development through packaged drug product.  Our mission is to provide flexible service options, transparent operations, and complete outsourcing capabilities to the global biotech community enabling our partners to bring their life-enhancing discoveries to patients.

Parenteral Manufacturing Associate:  These positions require the skills needed to support Parenteral Manufacturing operations – which include the formulation, filling, inspection, labeling, and packaging of injectable products.  

• (Prep/Filling): Responsibilities include setup, operation, troubleshooting, and cleaning of primary manufacturing equipment including: Vial and/or Syringe Filler, Isolator, De-bagger, E-beam, Lid Removal System, Capper, Washer, Depyrogenation Tunnel,  Equipment Washer, Autoclave, Terminal Sterilizer and Lyophilizer.

• (Dispense/Formulation): Responsibilities include dispensing and formulating bulk materials following batch records; set-up and operation of equipment (scales or balance, CIP/SIP, pH meter, down flow booth, tanks and vessels); execution of manufacturing procedures using SOPs, batch records, and equipment diagrams; and completing documentation according to CGMP requirements.

• (Service/Support): Responsibilities include sanitizing rooms and equipment (CIP/SIP); replenishing supplies; sampling and testing clean utilities; aseptically handling critical utilities (i.e. water for injection); transport and/or disposal of hazardous chemicals; performing environmental monitoring procedures; responding to system alarms; and documenting all processes according to CGMP requirements.

• (Inspection/Packaging): Responsibilities include inspecting product and containers for defects per quality specifications; packaging product and containers per batch record specifications; operating and cleaning basic packaging equipment (e.g., case tapers, pallet wrappers, barcode scanner, check weighers, scales, print-and-apply label stations); executing manufacturing procedures using SOPs and batch records; documenting processes according to CGMP requirements; and participating in and supporting process improvement initiatives. Requires 20/20 correctable near vision.

• (Equipment Operator): Responsibilities include providing setup, operating, troubleshooting, and cleaning automated equipment including: denester, labeler, cartoner, thermoformer, automated inspection, device assembly; operating and challenging machine vision systems; executing manufacturing procedures using SOPs, batch records, and equipment diagrams; inspecting components and equipment parts per quality specifications ; providing recommendations and implementing solutions to resolve equipment and or process problems in a timely manner; and documenting processes according to CGMP requirements.

All interested applicants must apply in person at:

Work One

450 S. Landmark Avenue

Bloomington, IN 47402

812-331-6000

Equal Opportunity Employer M/F/D/V