Role Purpose:

  • An exciting opportunity now exists at our client’s biopharmaceutical facility based in Co. Waterford for an experienced Senior Maintenance Technician.
  • The Senior Maintenance Technician will be reporting to the Technical Team Lead.
  • 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.
  • The successful candidate 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.

 

Core Duties and 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.

 

Education & Qualifications 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) advantageous.
  • 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.

Please note, we do not require agency assistance with this role.


Apply Now

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Role Details:

Job Title: Senior Maintenance Technician (shift)
Location: Waterford
Type: Permanent
Date: June, 2024
Image of recruitment specialist

Discuss with:

Ruth Holland
recruitment@prochem.ie
Recruitment Specialist
on +353 56 779 0100
Share:

Role Details:

Job Title: Senior Maintenance Technician (shift)
Location: Waterford
Type: Permanent
Date: June, 2024
Image of recruitment specialist

Discuss with:

Ruth Holland

recruitment@prochem.ie

Recruitment Specialist

on +353 56 779 0100

Share:

Role Purpose:

  • An exciting opportunity now exists at our client’s biopharmaceutical facility based in Co. Waterford for an experienced Senior Maintenance Technician.
  • The Senior Maintenance Technician will be reporting to the Technical Team Lead.
  • 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.
  • The successful candidate 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.

 

Core Duties and 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.

 

Education & Qualifications 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) advantageous.
  • 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.

Please note, we do not require agency assistance with this role.

Image of recruitment specialist

Discuss with:

Ruth Holland
recruitment@prochem.ie
Recruitment Specialist
on +353 56 779 0100
Share:

Apply Now

"*" indicates required fields

Full Name*
Accepted file types: pdf, docx, odt, doc, txt, Max. file size: 32 MB.
Accepted file types: pdf, docx, odt, doc, txt, Max. file size: 32 MB.
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