General Information

Country United States

City Irvine, California

Functional Area Operations

Job Group Maintenance & Facilities

Employment Type Permanent Contract

Working time Full-time

At its locations around the world, Siegfried offers employees exciting career opportunities in international settings. We cultivate multidisciplinary cooperation and encourage our staff to actively shape and influence their careers. This approach, coupled with our dynamic working environment, make Siegfried an attractive employer.

Your role

This is a 2nd Shift Maintenance Mechanic Position - 2:00 PM to 10:30 PM

Scope and Purpose of Position

This onsite position in Irvine, CA will focus on repair/corrective maintenance and preventive maintenance of the various production/laboratory instruments, machines and equipment in a drug and medical device manufacturing environment. This position will require flexibility with the work schedule to accomplish certain goals and required tasks

Responsibilities

  1. Conduct preventive maintenance per appropriate procedures on production and laboratory equipment
  2. Perform routine and non-routine corrective maintenance on the equipment related to production, laboratory and other functions within the organization
  3. Trouble shoot equipment failures and work with Engineering and Manufacturing to determine root cause and prevent recurrences of the failure
  4. Perform equipment repairs using proper aseptic technique while working in aseptic clean rooms.
  5. Provide support as required to the Engineering group on specific projects.
  6. Organize, track and keep updated all maintenance records.  Enter all information into Event Track on a timely basis.
  7. Troubleshoot PLC problems in conjunction with Engineering and make required repairs
  8. Provide mechanical and electrical/electronic technical support to both facilities and equipment.
  9. Evaluate effectiveness of the established maintenance procedures and suggest appropriate changes.
  10. Maintain the R/O water unit for sanitization and optimization.
  11. All other duties as assigned by supervisor.

Your profile

Required Knowledge, Skills and Abilities

  • Ability to work with various ranges of test equipment
  • Ability to work independently in a cGMP environment.
  • Ability to work with multimeters, test probes, micrometers and dial indicators.
  • Ability to read P&ID’s, isometrics, sketches and/or handwritten instructions.
  • Must have good communication and writing skills and works well in a project team environment.
  • Ability to diagnose and perform electrical repairs as required, AC (single and three phase) and DC (4 – 20 mA, 24 VDC).
  • Ability to assist in troubleshooting PLC problems.
  • Ability to interpret ladder logic, Allen Bradley and others.
  • Well organized in filling and tracking of daily maintenance records, and detail oriented.
  • Experience in repairs and maintenance of various production /laboratory instruments.  Familiarity with air over pressure and gravity feed autoclaves, steam generators, depryrogenation ovens, refrigerated storage areas, Water for Injection (WFI) and Reverse Osmosis (RO) water generation systems.
  • Preferred familiarity with de-gassing and Electronic De-Ionization systems.
  • Troubleshoot and repair mechanical components of HVAC systems, preferred but not required refrigerant license.
  • PC literate, for maintenance software and Microsoft products.

  • Experience in a majority of the following areas:
    1. Electrical
    2. Pneumatics
    3. Hydraulics
    4. Mechanical
    5. Electronics
    6. Calibration and Maintenance software

Required Education and Experience

  • Associate / Technical Degree or equivalent combination of education and experience
  • Minimum of 5-7+ years’ experience as maintenance mechanic or equivalent.
  • Science and math course work helpful
  • Pharmaceutical/medical device experience in a GMP environment
  • Hazmat Emergency Responder Certification preferred

Target Pay Range: $36-40/hour 
This is a 2nd Shift (2:00 PM - 10:30 PM) position - 2nd Shift employees receive a 10% Shift Differential

Working at Siegfried

Siegfried's work environment is dynamic and international. With a highly professional and motivated team, the company operates in a future-oriented business field. Siegfried possesses a unique culture that leverages cultural differences to create a competitive advantage. Siegfried places highest priority on providing a flexible, diverse and discrimination-free working environment in which employees can develop personally and professionally, advance innovation and deliver superior performance. We strive to provide a work environment where employees can take on challenging jobs and associated responsibilities that best serve their personal and technical development and can benefit from the success of our company. The company regulations in respect of compensation and career development opportunities apply to all Siegfried sites. Additional conditions of employment are governed by location-specific circumstances, legislation and customs.

Who we are

In the Midst of People’s Lives – Across the Globe

The Siegfried Group is one of the world’s leading Custom Development and Manufacturing Organizations (CDMOs) developing and producing active pharmaceutical ingredients (API), intermediates and finished dosage forms. As our core competence, we successfully integrate chemical and pharmaceutical capabilities into a single business model. 

The Siegfried name stands for highest quality, efficiency, flexibility and safety. Present in Europe, Asia and North America, we serve a broad global customer base from major international pharmaceutical companies down to small biologic-pharmaceutical organizations. For them we develop and produce product innovations on a large scale to finished products. We integrate our offer seamlessly into the customers’ value chain. Our comprehensive services range from early-stage Research & Development services such as synthesis, scale-up, formulation development, stability studies and method development all the way through to manufacturing services, ranging from preclinical R&D material for clinical trial purposes to commercial production. 

We are able to produce about 200 of the approximately 1500 registered drug substances used in medicine. Moreover, we produce 20 percent of global demand for caffeine. Consequently, nearly 1 billion individuals come into contact with Siegfried products.

What we do in Irvine

Irvine is one of Siegfried’s sterile drug product manufacturing sites, providing contract development and manufacturing services (CDMO) specializing in difficult to manufacture pharmaceuticals, ophthalmics, and drug delivery devices.

Main activities

  • Provides cGMP sterile drug product fill finish of biologics, suspensions, emulsions, ointments, and gels
  • All fully cGMP and SHE compliant

Features

  • Commercial Products: 5 automated filling lines, Commercial manufacturing, Batch sizes up to 150 K units, Fill Volumes 0.5 ml – 100 ml
  • Semi-automated and automated visual inspection
  • Automated packaging with digital data visual verification
  • Stability study services
  • Drug delivery
  • Laboratory services
  • Clinical Products small lot capability (semi-automated filling, batch sizes up to 5 K units)
  • Clinical manufacturing (batch sizes less than 5 K units)

Strategic importance

  • CDMO for innovative and difficult-to-manufacture products from clinical to commercial NDA and ANDA products
  • Provides contract sterile drug product manufacturing and laboratory services to the pharmaceutical and biotechnology industries

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