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Manufacturing Technician - II

Contract

San Mateo, CA

Posted on Oct 11, 2017

Works on basic assignments following established Standard Operating Procedures (SOPs), Master Batch Records and current Good Manufacturing Practices (cGMPs). Performs routine tasks associated with aseptic processing, dispensing, compaction, granulation, milling and coating.Reports to Team Lead on a regular basis on line performance and report any issues that need to be resolved.Performs basic troubleshooting of issues and escalates when required.Organizes routine tasks in an effective manner.Prepares equipment and components for sterilization.Operates processing equipment including autoclaves, ovens, vial washers, and depyrogenation tunnel.Cleans (manually and clean-in-place), assembles and disassembles 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 Basic Oracle and MES (Manufacturing Execution System) transactions.Performs data calculations.Cleans manufacturing areas, including walls, ceilings and floors.Accurately completes required documentation of events and tasks related to assigned work, including logbooks, batch records, etc.Reports variance or deviation from standard procedures to department management.Prepares coating solution.

Knowledge, Experience and Skills
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.

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
• Must be able to change into Gilead gowns and work attire as required for the task.
• Occasionally lift 50 lbs
• Routinely lift 25 lbs
Onsite Offsite: Onsite Offsite Onsite


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GDH Consulting, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, genetic information, veteran’s status or any other category protected by law. In addition to federal law requirements, GDH Consulting, Inc. complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities and/or employees. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, benefits and training.