Upstream Manufacturing Tech III
Proclinical is currently recruiting for an Upstream Manufacturing Tech III for a global pharmaceutical company located in Oceanside, CA. Successful candidate will have a Bachelor's degree or 3+ years of GMP experience and experience with aseptic techniques, SOPs, and batch records.
- Safety and Compliance are top priority.
- Participate in investigations and analyze accidents / incident that occur in the functional area and make improvements to minimize occurrence of accidents.
- Assure compliance with environmental and safety regulations.
- Involvement in planning and execution of all operations in a cGMP (Current Good Manufacturing Practice) environment.
- Media and buffer preparation.
- Generation and proliferation of cell cultures in shake flasks and fixed (stainless) and disposable bioreactors, centrifugation, and depth filtration.
- Clean in Place (CIP) and Steam in Place (SIP) of fixed tanks/vessels and portable equipment and Clean out of Place (COP) of miscellaneous parts and equipment.
- Proficiency and routine maintenance of analytical equipment including but not limited to: pH/conductivity meters, bioanalyzers, osmometers, benchtop centrifuges, cell counters and microscopes.
- Operation and practical knowledge of glass washers, autoclaves, filters, pumps and analytical equipment to support and monitor the process.
- 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.
- Coordinate daily activities and projects with support groups including: Automation, Engineering, Facilities, Process Development, Quality Assurance and Control, Calibration, Validation and Supply Chain.
- Works in conjunction with other manufacturing technicians under the guidance of a Team Leader.
- Follow established Standard Operating Procedures (SOPs), Master Batch Records (MBR's) and cGMPs.
- Perform troubleshooting as necessary and takes initiative in resolving issues.
- Sets up and operates equipment in classed clean room environment and completes all required paperwork using Good Documentation Practices (GDPs) in a timely and accurate manner.
- Interacts with scientists, engineers, and production staff.
Skills and Requirements:
- Bachelor's degree in Science, Engineering or related field or 3+ years of relevant cGMP experience.
- Knowledge of current Good Manufacturing Practices (GMPs).
- Quality systems, validation principles, regulatory and ICH guidelines, and multi-product controls.
- Background or understanding of Lean concepts (Kaizen, 5S, KanBan) desired.
- Background in disposable technology and multi-product facility desired.
- Good verbal, written, and interpersonal communication skills.
- Demonstrates ability and willingness to act both independently as well as with a team.
- Consistent positive attitude and demonstrated ability to learn new skills.
- Exhibits accountability, including taking ownership for words and actions and fulfilling commitments responsively.
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 Catherine Nguyen at (+1) 215-531-5643 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.