Biologic Support Operator II

Weil Group•Barceloneta, PR

3d•$19

About The Position

Purpose: Manufacture of bulk biologics products. Perform cleaning and sterilization procedures.Perform process tests and participate in qualification and validation activities asrequired. Assemble and inspect equipment in the manufacturing area to confirmoperational status. Work is performed in aseptic and non-aseptic environments.

Requirements

Associate Degree in Science, Mechanics, Electricity, Instrumentation or relatedfield.
No previous experience required.
Basic knowledge of laboratory techniques.
Basic mechanical and mathematical skills.
Basic verbal and written communication skills in English and Spanish.

Nice To Haves

Basic knowledge of computerized systems such as Delta V, MES and SAP preferred.

Responsibilities

Operate manufacturing equipment and instruments, such as tanks, autoclaves,filtration systems, washers, filter integrity testing, pH, amongst others.
Conductequipment setup (CIP, PT, SIP) operations according to the established procedures.
Manufacture of bulk biologics operations in Media & Buffer Formulation (CentralServices), 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 affectoperating and environmental conditions.
Monitor critical parameters and elevateany deviation that could impact operations to address accordingly.
Provide technical assistance to manufacturing areas, specifically thetroubleshooting support of equipment and process events.
Receive, inspect and verify materials availability to be used for the productionactivities.
Document, audit and timely correct manufacturing electronic or paper batchrecord 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), StandardOperating Procedures (SOP) and accurately complete process-associateddocumentation.
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 incidentreporting, use of PPE, waste management and disposal, and any other programapplicable according to the position duties.