Manufacturing Technician III - Protein Purification Manufacturing
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POST DATE 9/13/2016
END DATE 11/18/2016
Gilead Sciences, Inc
JOB DESCRIPTIONSPECIFIC RESPONSIBILITIES
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
Gilead Sciences is currently seeking a Manufacturing Technician III to provide full support in Protein Purification Manufacturing operations while operating in a dynamic and fast-paced team environment. Must have industry experience with GDP (Good Documentation Practices) and cGMP (Good Manufacturing Practices), and exhibit effective written and oral communication of deviations, incidents, and/or safety concerns, on a real-time basis.
The Manufacturing Technician III is responsible for the operation of large and small scale chromatography columns and skids, viral filtration and ultrafiltration/diafiltration 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.
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.
Involvement in planning and full execution/proper documentation of all operations associated with:
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
Proficiency and routine maintenance of analytical equipment including but not limited to: pH/conductivity meters, bioanalyzers, osmometers, benchtop centrifuges, cell counters and microscopes
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.
Must be flexible to work day, swing, or night shifts, and/or weekends
ESSENTIAL DUTIES AND JOB FUNCTIONS
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.
Performs manual handling of product loads and unloads tablets.
KNOWLEDGE, EXPERIENCE AND SKILLS
Knowledge of written Standard Operating Procedures (SOPs) and Master Batch Records
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 training others on a manufacturing process
Demonstrates capability in organizing more complex activities in a manufacturing process.
3+ years of relevant experience, HS Diploma and a Certificate to FETAC level 6 (GSL)
Prior experience in a cGMP related industry is required.
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact email@example.com for assistance.
For more information about equal employment opportunity protections, view the EEO is the Law poster at :