AbbVie

Biologics Operator

Employer
AbbVie
Location
Barceloneta, PR, United States
Posted
Nov 11, 2020
Ref
2007950
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 Biologics Operator I will be assigned to the 3rd shift and will perform tasks in one of the three areas of the process: Central Services, Fermentation and / or Purification. It will be assigned in the daily operations of production, operating equipment such as washing machines, autoclaves, CIP systems (Cleaning in Place), bioreactors, filtration systems, chromatography equipment. Weigh and verify the raw materials and necessary parts. Perform pH, conductivity, osmolality and filter integrity tests. It will monitor the alarm systems. Assemble equipment and perform cleaning and sterilization procedures. It will comply with the Good Manufacturing Practices (GMPs) and with the standard procedures (SOP's). Inform the coordinator of your performance area and the supervisor about any event that occurred during the shift.
  • Preparation of buffers and medias for use in the process of Fermentation, Capture and Purification.
  • Start recipes / worksheets using MES and / or DELTA V system.
  • Perform tests of pH, conductivity, Osmolality and filter integrity.
  • Monitor the alarm system.
  • Maintain electronic records and detailed paper of the operations performed, "Batch records," "log books," and perform the required inventory transactions.
  • Performed standardized bench Top pH Meter, Conductivity Meter and Osmometer
  • Perform Inventory Adjustment MES / SAP
  • Review and modify different SOP'S related to equipment and process in Manufacturing areas.
  • Audit batch record and log book of Buffer and Media
  • Perform cleaning of portable and fixed tanks using CIP(Clean in place) and SIP(Steam in place)
  • Monitors and evaluates parameters in existing (on-going) processes to optimize process times/productivity, equipment performance, yields and quality.
  • Writes, evaluates and revises the required manufacturing documentation.
  • Performs testing, sampling and inspection for raw materials/excipients, packaging and components.
  • Performs cleaning and environmental monitoring activities on API and Raw Materials Rooms.
  • Make changes to documents such as: SOPs, protocols, methods, operational procedures, etc.

Qualifications
  • Associate Degree in Natural Sciences, preferably in Chemistry, Biology, Microbiology or related areas.
  • Associate Degree in Electronics or Mechanics with one (1) year of experience in the area of biotechnological processes.
  • Experience in the area of manufacturing or quality in the chemical, pharmaceutical or biological processes industry, strongly prefer.
  • Knowledge of laboratory techniques.
  • Knowledge of computerized systems, desirable Delta V, MES, SAP.
  • Verbal and written communication skills in English and Spanish with reading skills and comprehension of technical documentation in English.
  • Mathematical and Basic mechanical skills
  • Available to work with compressed itineraries, to work shifts including weekends and rotating. Must be available to work from Sunday to Thursday.
  • Ability to work in team with good interpersonal skills.
  • Basic skills for identification and analysis of problems and chemical and biological manufacturing processes.
  • Transportation of heavy equipment.
  • Knowledge of Good Manufacturing Practices (cGMP's) and safety standards.

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.