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Manufacturing Process Technician - Inspection - Fixed Term Contract

2+ years
Not Disclosed
10 Dec. 3, 2024
Job Description
Job Type: Full Time Education: BE/B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Manufacturing Process Technician
Location: Amgen Manufacturing Site
Contract Type: Fixed Term Contract (24 months)


Job Description Summary:

The Manufacturing Process Technician at Amgen plays a vital role in the operation and maintenance of manufacturing equipment. This individual ensures the quality and safety of final products by monitoring, adjusting manufacturing processes, troubleshooting issues, and complying with company policies and safety regulations. They will report directly to the Shift Manager and may be responsible for tasks such as the operation and setup of manufacturing equipment, parts processing, electronic system transactions (e.g., EBR, LIMS, SAP), and cleaning and sanitization of production areas.

This role is part of a continuous improvement culture, requiring flexibility to carry out additional duties not specifically listed in the job description. The position requires working in various shift patterns, including days, 2, 3, and 4 cycle shifts.


Key Responsibilities:

  • Manufacturing Operations:
    Operate and set up manufacturing equipment, perform transactions in electronic systems, and ensure the sterilization of components for parenteral drug production.

  • Troubleshooting & Problem Solving:
    Monitor and adjust manufacturing processes, address issues promptly, and initiate investigations when problems arise.

  • Quality & Safety Audits:
    Perform self-inspection and Quality & Safety Audits within the functional area to ensure compliance with Good Manufacturing Practices (GMP).

  • Learning & Development:
    Participate in cross-training programs, goal setting, and Maximizing Amgen Performance (MAP) annual reviews. Help train and mentor colleagues to develop their skills.

  • Process Improvement:
    Proactively identify opportunities for improvement in manufacturing processes and escalate issues to senior associates or engineers for effective resolution.

  • Regulatory Compliance:
    Contribute to regulatory audits, including support for Corporate, FDA, HPRA, and other regulatory bodies.

  • Safety Practices:
    Serve as a champion for safe working practices, ensuring a safe and compliant work environment.

  • Sampling, Testing & Calibration:
    Conduct required sampling, testing, inspections, and perform calibration and maintenance of test equipment.

  • Additional Duties:
    Perform any other duties as directed by the supervisor/management.


Qualifications:

  • Education:

    • Minimum of Leaving Certificate or equivalent (five passes, including English and Mathematics).
    • A third-level qualification in a relevant discipline is an advantage.
  • Experience:

    • Some relevant experience in the operation of manufacturing functions in a sterile pharmaceutical manufacturing or similar environment.
    • Understanding of RFT (Right First Time) techniques and lean manufacturing concepts.
  • Skills & Abilities:

    • Strong organizational and communication skills with the ability to work both independently and in a team.
    • Proven ability to achieve team and personal objectives.
    • Mechanical aptitude and troubleshooting skills.
    • Ability to deliver results in a fast-paced, regulated environment.

Preferred Skills:

  • Experience with Manufacturing Equipment:
    Familiarity with equipment used in the manufacture of parenteral products such as automated visual inspection, filling lines, and formulation vessels.

  • Problem-Solving & Initiative:
    Ability to approach problems creatively and work on solutions autonomously, as well as in a team setting.


Apply Now to join Amgen and contribute to the manufacturing of life-changing, high-quality products that make a difference to patients' lives.