NHS Human Services, Inc.

We have ambitious plans and have an exciting opportunity at our Waterford Facility for a permanent full time Maintenance Technician reporting to the Technical Team Lead.

The Company

Amgen recently acquired Horizon Therapeutics. We are excited to join forces, drawing on our unified expertise and shared mission to deliver first-in-class medicine to patients around the world suffering from serious illness.

Position Summary:

As a Maintenance Technician, you’ll play an important role in being a maintenance subject matter expert in all systems associated with the Sterile Fill Finish Operation. You will also have responsibilities to maintain equipment/systems in non-GMP areas that are critical to the manufacturing process.

Please note this is a shift position. The role will also be required to support an on-call roster.

Responsibilities:

Maintenance and Operations

• Support the Operations Team through troubleshooting process equipment problems to ensure reliable operation of the plant.

• Ensuring all routine maintenance work (PM, PdM & Cal’s) is completed to planning and scheduling requirements.

• Ensuring that there are minimal or no breakdowns or disruptions in the Production, Utilities or Facilities processes.

• Keeping a record in the CMMS of all service, maintenance and refurbishing works carried out on the equipment.

• Supervising outside contractors/vendors to maintain equipment in validated state to support Production and Utilities.

• Compiling and developing Service Level Agreements for equipment and systems. Monitoring performance of the services provided by service providers to ensure that they perform to company standards

• Leading and supporting Continuous Improvement and change within respective areas and systems

• Working closely with all customers and support functions to ensure Regulatory Compliance (FDA, HPRA, EPA, etc) and prompt customer service

• Ensuring all areas of responsibility are in compliance with GMP regulations

• Compliance to all site Environmental, Health and Safety requirements, training and regulations.

• Ensure critcial spare parts requirements are available and cost-effective for equipment.

• Develop Maintenance SOPs, Work Instructions (WI) and Preventative Maintenance (PM) instructions to ensure all maintenance activities are performed safely, and in accordance with approved procedures.

• Support Project activities as required to ensure Maintenance and Operational requirements are included. FAT attendance, commissioning and qualification support.

Health, Safety and the Environment

• Comply at all times with the Health, Safety and Environmental policy and associated procedures.

• Continuously promote a positive safety culture by challenging yourself and others to prioritize safety in everything you do.

Quality Compliance

• Ensure all work carried out, complies with the required standards, conforming to company, cGMP, cGLP, SOP’s and regulatory guidelines.

• Take ownership of quality compliance in all activities you are responsible for.

Qualifications and Skills Required:

• Fully qualified to National Craft Standard or equivalent 3rd Level Qualification

• Minimum 2 years’ maintenance experience in the Biopharmaceutical industry or similar cGMP manufacturing experience (API, OSD, Med Device, Infant Formula, etc)

• Multi-skilled – Primarily Electrical with an understanding of Calibration and Instrumentation. Basic mechanical knowledge would be an advantage also.

• Desirable equipment experience: Vial / PFS Fill Line, Isolator, CLU, Autoclave, Parts Washer, Inspection Machine, Lyophiliser, HVAC, WFI / PUW, Process Air / Nitrogen, Safety & Electrical (MV / LV) Systems.

• Experience with problem-solving skills, troubleshooting, and setup of process equipment.

• Ability to interpret P&IDs, equipment/system layouts, wiring & pneumatic diagrams, etc.

• Must be knowledgeable of the GMP regulatory requirements for maintenance activities.

• Proficient in the use of CMMS, experience in PEMAC, MAXIMO or SAP PM preferable.

• Operate and retrieve/interpret data from control systems (SCADA, QBMS, BMS).

• Audit experience providing technical assurance, (FDA, HPRA, EPA, etc) advantageuous.

• Lean Six Sigma experience for the use of problem solving

• Experience in drafting SOPs, WIs and PMs would be an advantage.

• Proficient in the use of Microsoft Office and other computer applications.

• Excellent interpersonal, written and verbal communication skills.

Essential Core Values and Competencies :

We value and look to recruit people with these values and competencies. Have you got the following skills?

Growth:

• Manages Ambiguity

• Strategic Mind-set

• Demonstrates Self-awareness

• Cultivates Innovation

• Develops Talent

Accountability:

• Drives Results

• Ensures Accountability

• Decision Quality

Transparency:

• Courage

• Collaboration

• Instils Trust

Amgen is an equal opportunity employer