ZL01-051325 Biologic Operator II

7 days ago

Barceloneta PR, United States Validation & Engineering Group Full time

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

  • Biologic Operator II

Qualifications:

  • Associate Degree in Science, Mechanics, Electricity, Instrumentation or related field. No previous experience required. Basic knowledge of laboratory techniques.
  • Basic knowledge of computerized systems such as Delta V, MES and SAP preferred.
  • Basic mechanical and mathematical skills.
  • Basic verbal and written communication skills in English and Spanish.

Third shift position, trainings will be taken for 1-2 months on First shift.

Candidate must be available to work any shift based on business needs.

Responsibilities:

  • Operate manufacturing equipment and instruments, such as tanks, autoclaves, filtration systems, washers, filter integrity testing, pH, amongst others.
  • Conduct equipment setup (CIP, PT, SIP) operations according to the established procedures.
  • Manufacture of bulk biologics operations in Media & Buffer Formulation (Central Services), Inoculum or Fermentation (Upstream) and Capture or Purification (Downstream) areas according to approved and effective procedures.
  • Conduct equipment and facility inspections and advise of situations that affect operating and environmental conditions.
  • Monitor critical parameters and elevate any deviation that could impact operations to address accordingly.
  • Provide technical assistance to manufacturing areas, specifically the troubleshooting support of equipment and process events.
  • Receive, inspect and verify materials availability to be used for the production activities.
  • Document, audit and timely correct manufacturing electronic or paper batch record discrepancies.
  • Document process and equipment status in electronic or manual records.
  • Sample collection and processing as required by the process.
  • Strict adherence to current Good Manufacturing Practices (cGMP's), Standard Operating Procedures (SOP) and accurately complete process-associated documentation.
  • Provide assistance to operations in accordance with environmental management, occupational health and safety (EHS) systems and promote continuous improvement.
  • Comply with all EHS procedures and policies including incident reporting, use of PPE, waste management and disposal, and any other program applicable according to the position duties.

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