Job Title : Biologics Operator II
Purpose :
Describes the primary goals,objective or function or outputs of this position.
Manufacture of bulk biologics products. Perform cleaning and sterilization procedures. Perform process tests
and participate in qualification and validation activities as required. Assemble and inspect equipment in the
manufacturing area to confirm operational status. Work is performed in aseptic and non-aseptic environments.
Responsibilities :
List up to 10 main responsibilities for the job. Include information about the accountability and scope.
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..
Qualifications :
List required and preferred qualifications up to 10). Include education, skills and experience.
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.
Candidates must available to work any shift/weekends and holidays.
What are the top 3-5 skills, experience or education required for this position:
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.
