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Job Description


Maintenance Specialist

View: 515

Company: Roche
Contract: PERM
Location: Oregon - Hillsboro, United States


Main Purpose of the Position:

Under the direction of Manufacturing Supervisor or other qualified Operations Specialist, perform a wide variety of tasks and operations that are required to package sterile pharmaceutical products in a state-of-the-art, automated production and packaging facility.  Troubleshoot, maintain, and assemble all production equipment as required.  Lead or Assist the Operations Specialist on major equipment overhauls, repairs, and installations as necessary.  All operations will be carried out in compliance with cGMPs, Standard Operating Procedures (SOPs), product recipes, and Genentech standards.

In addition to performing the responsibilities/tasks below, the successful candidate will need to demonstrate the following traits:

  • Passion and drive to develop and maintain a LEAN culture dedicated to providing the best results for our internal and external customers.
  • Continuously in search for ways to maintain the highest levels of equipment reliability and share those best practices with other Operations Specialists and support functions.
  • Actively participate in a teamwork environment that maintains a high performance culture.
  • Discretion when utilizing higher access levels of equipment automation systems during preventative maintenance and while troubleshooting issues in order to reduce planned and unplanned downtime.
     

Responsibilities:

  • Adhere to all plant safety policies and procedures and proactively identify unsafe conditions.
  • Perform safety and housekeeping audits as required.
  • Assist in set up, change over, and test run equipment for various-sized vials and packages as required.
  • Supporting the Production Maintenance and Instrumentation, and/or outside services in the repair, maintenance, and calibration of GNE Systems as required.
  • Perform training of other Technicians and Operations Specialists.
  • Assist in the development of plant SOP’s and training materials.
  • Execute production recipes as needed, check-in equipment, and perform material movements using automated computer software applications (SAP and MES systems).
  • Assist in the cleaning, set-up, and disassembly on a variety of processing equipment.
  • Prior to start-up, during processing, and at the completion of the manufacturing process, perform all documentation and clerical functions to provide the proper accountability and traceability of components and finished product.
  • At the start and finish of each shift, report and make recommendations regarding equipment, supplies, required repairs, process concerns, safety concerns, and areas for improvement in reliability, yield, and efficiency.
  • Work effectively and efficiently in a team-oriented environment to ensure maximum and high-quality output.
  • Perform cleaning and housekeeping duties as required to ensure a safe environment.
  • Be the department representative and assist with PMs and major equipment improvements/upgrades.
  • Adjust work schedule as needed (ex: weekend work, extended work day) to support PMs, major equipment improvements/upgrades and equipment troubleshooting to ensure equipment is ready when turned over to production.

Requirements:
 

Proficiency in the English language – reading, writing, and communication.  Must be able to work all shifts (1st, 2nd, or 3rd), required overtime as needed, able to lift 45 pounds, and stand for extended period of time.  Must be able to successfully pass all job-related tests and certifications required for working in a cGMP, quality environment including but not limited to: inspections and GMP requirements to perform essential functions of the job.  Must re-qualify every year on all job-related tests and certifications as job or qualifications require.  All candidates must pass a vision acuity and color discrimination test.

Education:

  • High school diploma or equivalent AND
  • Graduate of a two-year Associates Degree program in Electrical/Mechanical Technology (or equivalent) AND
  • Bachelor degree in Electrical/Mechanical Technology (or equivalent) is a plus

Experience:

  • 5 to 6 years (within the last 7 years) experience in the maintenance and troubleshooting of complex mechanical and electrical equipment used in the washing, filling, conveying, sealing, inspection and packaging of products/containers is highly desirable.  Target industries include pharmaceutical, biotechnology, biomedical, electronic, and chemical, food, cosmetics, and/or other medical industries.

Computers:

Must be computer literate, including ability to interface with computer systems and PLC-based logic.  Must be comfortable working with Microsoft suite (Word, Excel, PowerPoint), navigating through web pages and e-mail.  Must possess basic typing skills.

Job descriptions are not intended, and should not be construed, to be all-inclusive lists of all responsibilities, skills, efforts, or working conditions associated with a job.  While this description is intended to be an accurate reflection of the job requirements, management reserves the right to modify, add, or remove duties and to assign other duties as necessary.

 
 
 
 
 
 
 





More Info / Apply

(external link to recruiter web page)








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