Location: Barceloneta, PR
Pay Rate: $18.11 / Hourly

Purpose:

• Manufacture of bulk biologic products. Perform cleaning and sterilization procedures. Perform process tests and participate in qualification and validation activities as required. Assemble and inspect equipment and non-aseptic environments.

Responsibilities:

• Operate manufacturing equipment and instruments, such as tanks, autoclaves, filtration systems, washers, filter integrity testing, pH, among others.
• Conduct equipment setup (CIP, PT, SIP) operations according to the established procedures.
• Manufacture of bulk biologic 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:

• Associate Degree in Science (microbiology, chemical, chemical process are preferred on related fields), Mechanics, Electricity, Instrumentation or related field.
• No previous experience required.
• Availability to work all shifts, non-standard shifts, overtime, and weekends.
• 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.

 

 


At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $18.11/hr.