Manufacturing Science Technician V

Allergan - Irvine, CA (30 days ago)3.8


Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.

Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.

Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients. Power your future & join our bold team.

Position Overview

Responsible for the proper operation of all facility and process systems required to operate a Good Manufacturing Practices (cGMP) and Non-GMP manufacturing facility. Responsible for instrument diagnosis, repair and calibration of all systems including but not limited to: autoclaves, purified water distribution systems, mixers, incubators, refrigerators, freezers, process pumps, electric motors and air handling units.

This position will be responsible for coordinating and/or implementing unscheduled repair of equipment, instruments and devices as describe in the service request system, schedule outside vendors to perform maintenance, and logistical support to maintain readiness and uninterrupted support to all Pharmaceutical Development departments.

This position requires the ability to a pass clean room gowning qualification for both sterile and non-sterile gowning and work within manufacturing clean rooms as necessary.

This position has full responsibility and authority to make necessary decisions and/or take action which is required to carry out job duties.

This position operates in an environment working with other Pharmaceutical Development

Departments, Plant Services, and contract vendors.

Main Areas of Responsibilities

1. Maintain, and perform equipment & instrumentation troubleshooting on the critical systems required to operate a GMP & Non-GMP facility to include:

  • Autoclaves
  • HVAC control system, Dehumidifier control, Re-circ blowers, Deionization controller, and Humidifier controllers
  • Clean Steam system and Plant Steam controllers
  • Water for Injection systems, DI water, TOC analyzers
  • Labwatch system controller
  • Refrigerators, Incubators, Freezers, Dryers, Washers, etc.
  • Bioreactors
  • Process Chilled Water systems
2. Responsible for the proper operation, troubleshooting, and maintenance of all manufacturing process equipment. Execute routine and non-routine calibration and maintenance activities in a timely manner.

3. Assist/supervise all contractors to assure that work is done properly, and safety guidelines are observed.
4. Maintain proper control of operations by following SOP's, Manufacturing Procedures, GMP's, ISO requirements, OSHA guidelines, and other pertinent regulatory requirements.

5. Responsible for the scheduling and supervision of outside vendors.

6. Assist in the installation and support qualification of manufacturing equipment and monitoring devices in the GMP and non-GMP facilities.

Requirements

Physical Requirements and Working Conditions:
  • May require knowledge of chemicals and their characteristics.
  • Required to lift up to 50 pounds.
  • Must be able to use required hand tools Must be able to work overhead, bend, stoop, and work in awkward positions.
  • Must be able to climb ladders
  • Must be able to a pass clean room gowning qualification and work within manufacturing clean rooms in full body gowning
  • Must be able to work in confined spaces
  • Exposure to loud noises, high temperature reciprocating machinery
  • Environment may contain dirt, dust, grease, solvents, chemicals, and drug substances
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Minimum Qualifications:
Four to six years of hands on experience in a pharmaceutical processing environment and/or medical device manufacture in a cGMP manufacturing environment.
Ability to calibrate, troubleshoot, repair and operate autoclaves, pharmaceutical water systems and HVAC equipment