Production Support Operator

Production Support Operator

Our client provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. Summary: The main functions of the Sterile Filling Area are to set up and operate filling/sealing-automated equipment in a cleanroom environment. In addition, clean and sanitize the equipment and areas that are utilized for the filling/sealing operation. Operation occurs in a cleanroom environment and is governed by strict standards of sterility and regulatory agencies. The operators in this area aseptically fill parenteral products in liquid and lyophilized (freeze-dried) form, seal the vials, and ensure that Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMPs) are followed at all times.

Essential Duties and Responsibilities:

• Comprehend and follow SOPs, cGMPs, and good aseptic techniques to produce sterile quality products.
• Aseptically assemble and operate automated filling equipment & sealing equipment.
• Aseptic gowning for various classifications of cleanroom areas
• Documentation and review of associated paperwork for accuracy and clarity.
• In-process inspection or pre-inspection of vials as necessary.
• Stock gowning materials for gowning.
• Cleaning and sanitization of work areas.
• Working with peers to help train each other as directed by Production Management.
• Other duties as assigned

Supervisory Responsibilities: This job has no supervisory responsibilities.

Education and/or Experience: High school diploma or general education degree (GED); two (2) years of related experience (production, manufacturing, cleanroom), and pass pre-employment assessments.

Language Skills: Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

Mathematical Skills: Ability to add, subtract, multiply, and divide into all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.

Reasoning Ability: Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.

Computer Skills: Knowledge of Internet software; Manufacturing software; Spreadsheet software and Word Processing software.

Other Skills and Abilities: Comprehend and follow SOPs, cGMPs, and detailed instructions to successfully produce sterile quality products. Document information, events, and cGMP manufacturing processes, accurately, and completely. Perform duties in an organized, detail-oriented manner. Apply basic math: measures, weights, fractions, and decimals. Apply basic computer skills. Work and communicate well with others in a team environment.

Other Qualifications: Must be able to obtain and maintain gowning certification. Must be able to wear a respirator Pass a background check, a drug screen, and a physical.

Physical Demands: While performing the duties of this job, the employee is regularly required to talk or hear. The employee is required to stand for long periods of their shift; walk; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, and depth perception.

Work Environment: The work environment characteristics described here are representative of those an employee encounter while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this Job, the employee is regularly exposed to toxic or caustic chemicals. The employee is frequently exposed to moving mechanical parts; fumes or airborne particles; risk of electrical shock; explosives; risk of radiation and vibration. The employee is occasionally exposed to wet and/or humid conditions; extreme cold and extreme heat. The noise level in the work environment is usually moderate.

Our client is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.