Manufacturing Technician - III
Proclinical is currently recruiting for a Manufacturing Technician - III with an international biopharmaceutical company located in Oceanside, CA. Successful candidate will be responsible for the operation of large and small scale chromatography columns and skids, viral filtration and ultra-filtration/dia-filtration skids, as well as all related equipment and systems necessary to clean, configure, sanitize/sterilize and maintain said equipment.
- Operation and practical knowledge of glass washers, autoclaves, filters, pumps and analytical equipment to support and monitor the process is expected.
- Safety and Compliance are the two primary objectives of manufacturing operations.
- Reports to Team Lead on a regular basis on line performance and reports any issues that need to be resolved.
- Expected duties also include planning and executing the safe and efficient operation of assigned processes, Good Documentation Practices, timely communication of deviations, incidents and/or safety concerns and all relevant housekeeping duties to ensure the work areas are kept to a high level of cleanliness and inspection readiness.
- Protein Purification by means of column chromatography, Viral Filtration and UFDF.
- Clean in Place (CIP) and Steam in Place (SIP) of fixed tanks/vessels and portable equipment and Clean out of Place (COP)/Glasswash of misc. parts and equipment.
- Maintain analytical equipment including but not limited to: pH/conductivity meters, bioanalyzers, osmometers, benchtop centrifuges, cell counters and microscopes.
Skills and Requirements:
- A minimum 3 years of relevant experience, HS Diploma and a Certificate to FETAC level 6 (GSL).
- 0 - 2 years of relevant experience with a Bachelor's degree in engineering or scientific discipline.
- Prior experience in a Biologics cGMP related industry is required.
- Knowledge of written Standard Operating Procedures (SOPs) and Master Batch Records.
- Experience with DeltaV Automation Systems and Unicorn System Control or equivalent.
- Aseptic Processing experience and knowledge required.
- Knowledge of quality systems, validation principles, regulatory and ICH guidelines and multi-product controls required.
- Background or understanding of Lean concepts (Kaizen, 5S, KanBan) desired.
- Works under demanding production schedules and strict compliance/quality requirements.
- Coordination with support groups including, but not limited to: Process Development, Quality Assurance and Control, Calibration, Maintenance, Validation, and Materials Management as a Manufacturing representative
- Ability to work independently and in teams, proactive and self-managing, proven problem solving as well as a detailed and organized approach are key components to the success of this candidate.
- Good verbal, written, and interpersonal communication skills are required.
- Working knowledge in Microsoft Office applications and administrative policies.
- Ability to follow direction and work under minimal supervision.
- Demonstrates capability in organizing more complex activities in a manufacturing process.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Brendan Thalheimer at (+1) 215-531-5299 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.