A leading US biopharmaceutical organisation with a solid commercial portfolio of life-saving drugs within a number of therapy areas have a new Manufacturing Technician job opportunity at their offices in La Verne, CA. The company has a growing pipeline of investigational drugs and approximately 5,000 employees in offices across four continents. This Manufacturing Technician role is a contract position.
- Works on basic to routine assignments following established Standard Operating Procedures (SOPs), Master Batch Records and current Good Manufacturing Practices (cGMPs).
- Performs moderately complex tasks associated with aseptic processing, dispensing, compaction, granulation, milling and coating.
- Reports to Team Lead on a regular basis on line performance and reports any issues that need to be resolved.
- Performs more complex troubleshooting unassisted
- Works on more complex manufacturing processes and assignments
- Assembles, disassembles and operates aseptic filling equipment and lyophilizer autoloading equipment in classed cleanroom environments.
- Prepares equipment and components for sterilization.
- Operates processing equipment including autoclaves, ovens, vial washers, and depyrogenation tunnel.
- Cleans (manually and clean-in-place) and assembles equipment for production.
- Performs clean-in-place and sterilization-in-place of tanks.
- Performs annealing and sterile filtrations of products.
- Operates vial capper, unloads product from lyophilizers, and packs off unloaded vials from lyophilizers and liquid fill line.
- Performs detailed /Oracle (computerized software) and MES transactions in resolving inventory discrepancies.
- Cleans manufacturing areas, including walls, ceilings and floors.
- Creates purchase orders for consumables.
- Completes and maintains documentation related to assigned work, including logbooks, batch records, etc.
- May act as point of contact for a compliance audit.
- Operates drum coater and compression equipment.
- Dispenses ingredients for batches.
- Performs MBR Manufacturing batch report updates.
Skills and Requirements:
- Knowledge of current Good Manufacturing Practices (GMPs).
- Demonstrates good verbal, written, and interpersonal communication skills.
- Receives general instructions on routine work, and detailed instructions on new assignments.
- Follows written Standard Operating Procedures (SOPs) and Master Batch Records and must be able to take variant action only with approval of department management.
- Independent action and initiative in resolving issues.
- Previous experience operating a forklift or powered industrial truck.
- Demonstrates strong safety orientation, with strict adherence to established safety practices and standards.
- Takes independent action and initiative in resolving issues.
- 5+ years of relevant experience, HS Diploma, and a Certificate to FETAC level 6 (GSL)
- Prior experience in a cGMP related industry is required.
- Must be able to work on a rotational shift schedule alternating between day shift and grave shift.
- Must be able to work 12-hour shift schedules.
- Must be able to work weekends
- Must be able to work holidays
- Must be able to operate and qualify for respirator usage
- Must be able to see and distinguish all colors and shades
- Must be able to stand for a continuous 4 hours
- Occasionally lift 50 lbs
- Routinely lift 25 lbs
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 Eleni Farrell on +1 267 405 6996 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.