AbbVie

Operator, Biologics II

Employer
AbbVie
Location
Barceloneta, PR, United States
Posted
Oct 10, 2020
Ref
2007149
Required Education
Associate Degree
Position Type
Full time
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

The Biological Operator II will be assigned to the daily production operations operating different equipment. The incumbent will perform process tests and participate in qualification and validation activities as required. The incumbent will monitor alarm systems. He / she will assemble and inspect equipment in the manufacturing area to confirm its operational status. Perform cleaning and sterilization procedures. He /she will comply with the Good Manufacturing Practices (GMP's) and with the standard procedures (SOP's). Will work aseptically or as required by the classification of the production area. Inform the coordinator of his / her performance area and the supervisor about any event that occurred during the work shift. The incumbent will review his / her own documentation and that of others, ensuring that it is correct and complete.

Main Responsibilities:
  • Diagnose and resolve events or exceptions of highly complex equipment and processes through the interface of systems such as "Human Machine Interface" (HMI), "Process Logic Controls" (PLC).
  • Management and disposal of domestic, biomedical, and hazardous waste from their respective area as applicable, ensuring compliance with local and federal regulations following the procedures and policies of the plant, division, and the corporation.
  • Carry out cleaning operations, pressure testing, sterilization of equipment, integrity of filters and gloves of the "RABS", filtration of solutions, aseptic filling and automatic or manual inspection of the product, as applicable.
  • Keep detailed records, manual or electronic, of the operations carried out during the work shift, audit "batch records", "log books", and perform the required inventory transactions.
  • Management and disposal of domestic, biomedical, and hazardous waste from their respective area as applicable, ensuring compliance with local and federal regulations following the procedures and policies of the plant, division, and the corporation Inspection the equipment to verify that they are operating within the established parameters.
  • Perform tests of pH, BGA, conductivity, osmolality, density, concentration, filter integrity, as applicable.

Qualifications
  • Associate Degree in Natural Sciences, preferably in Chemistry, Biology, Microbiology or related areas. Incumbent can have an Associate Degree in instrumentation, automation, electronics, mechanics or business administration.
  • Must have experience in aseptic techniques and sterile product filling.
  • At least five (5) years of experience in a Manufacturing area in the Chemical, Pharmaceutical, medical devices or Biological Processes industry.
  • Preferable two (2) years of experience as a Biological Operator in (SVP) Biological Processes and/or Biotechnology Plant.
  • Knowledge of laboratory techniques and computerized systems required, preferable in Delta V, MES and SAP.
  • Annual vision tests and ability to inspect parenteral product are required in manufacturing of parenteral biological products (SVP).
  • Basic mechanical and mathematical skills required.

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.