Role Summary:

  • A fantastic vacancy has arisen for a Sterilisation Process Engineer Lead to join our client’s new manufacturing facility in Co. Kilkenny.
  • In this role you will be the Specialist in the Pharmaceutical/Biological Process Sterilisation Sub-Function, considered as highly experienced and knowledgeable resource within the organization in implementing and maintaining pharmaceutical processes.
  • You will also have the opportunity to travel to vendor locations for training in Europe and worldwide.

 

Core Duties and Responsibilities:

  • As a Process Engineer Lead in e-beam Sterilisation you will be required to:
  • Provide product and manufacturing support in a cGMP regulatory environment.
  • As part of a cross functional team liaise with equipment suppliers and perform and manage equipment installations. (SAT/FAT)
  • Monitor machine performance (OEE/KPI’s) in real time to maximise production output.
  • Contribute to analytical development through design and execution of experiments, data analysis and communication of conclusions through presentations and reports.
  • Coordinate and contribute to the design of Ops, protocols, specifications, and validation documentation (IQ/OQ/PQ).
  • Develop and drive the site sterilisation program, updating as appropriate.
  • Supervise in implementing and maintaining the sterilisation processes for the site.
  • Manage and co-ordinate all sterilisation activities, including coordination with providers and suppliers.
  • Model processes and unit’s operations.
  • Write documentation for sterilisation process flow, support equipment validation and provide guidance and feedback.
  • Ensure equipment maintains its validated state.
  • Ensure that all work conducted is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs).
  • Drive the sterilisation training program, knowing safety rules and regulations, and making sure all personal are trained on safe work practices.
  • Seek opportunities for significant, process or product improvements, considering critical quality attributes, critical process parameters, and product performance characteristics.
  • Develop and maintain project timelines and provide updates and feedback to leadership.
  • Data management, trending (including SPC) and reporting of product performance and other business measures.
  • With appropriate training become a subject matter expert in process & product.
  • Service, troubleshoot and solves engineering problems with processes or equipment already in operation.
  • Ensures processes and procedures are in compliance with regulations.
  • Initiate and complete CAPAs and Change Controls in accordance with site procedures.
  • Liaise with key business stakeholders; QA, Manufacturing, Engineering, R&D, Regulatory Affairs and Purchasing to ensure timely completion of activities.
  • Excellent communication / interpersonal skills
  • Proven Technical writing skills with proven capability in providing rationale for equipment and processes.
  • Mentor coach and co-ordinate a team.

 

Minimum Qualifications and Experience:

  • A relevant third level qualification in Engineering/Manufacturing/Science, Mechanical, Electrical, Electromechanical is preferred.
  • Minimum 5 years’ experience in the Engineering/Manufacturing/ Scientific field.
  • Ability to interpret data, discuss findings and resolve complex analytical problems.
  • Recognize adverse trends and emerging issues. Propose and implement solutions to internal and external issues.
  • Strong problem solving.
  • Strong mechanical and electrical ability with computer experience, MS Excel & Word are essential.
  • Computer statistical skills will provide immediate expertise for the trending and reporting of data.
  • Must possess good organizational skills and attention to detail.
  • Demonstrate Leadership qualities are a distinct advantage.
  • Demonstrated flexible and innovative approach to work.
  • Electron beam, Gamma, or other sterilisation technologies experience desirable.
  • Knowledge in ISO 11137 desirable.
  • Travel 15% of time

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


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Role Details:

Job Title: Process Engineer Lead – Sterilisation
Location: Kilkenny
Type: Permanent
Date: February, 2024
Image of recruitment specialist

Discuss with:

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

Role Details:

Job Title: Process Engineer Lead – Sterilisation
Location: Kilkenny
Type: Permanent
Date: February, 2024
Image of recruitment specialist

Discuss with:

Ruth Holland

recruitment@prochem.ie

Recruitment Specialist

on +353 56 779 0100

Share:

Role Summary:

  • A fantastic vacancy has arisen for a Sterilisation Process Engineer Lead to join our client’s new manufacturing facility in Co. Kilkenny.
  • In this role you will be the Specialist in the Pharmaceutical/Biological Process Sterilisation Sub-Function, considered as highly experienced and knowledgeable resource within the organization in implementing and maintaining pharmaceutical processes.
  • You will also have the opportunity to travel to vendor locations for training in Europe and worldwide.

 

Core Duties and Responsibilities:

  • As a Process Engineer Lead in e-beam Sterilisation you will be required to:
  • Provide product and manufacturing support in a cGMP regulatory environment.
  • As part of a cross functional team liaise with equipment suppliers and perform and manage equipment installations. (SAT/FAT)
  • Monitor machine performance (OEE/KPI’s) in real time to maximise production output.
  • Contribute to analytical development through design and execution of experiments, data analysis and communication of conclusions through presentations and reports.
  • Coordinate and contribute to the design of Ops, protocols, specifications, and validation documentation (IQ/OQ/PQ).
  • Develop and drive the site sterilisation program, updating as appropriate.
  • Supervise in implementing and maintaining the sterilisation processes for the site.
  • Manage and co-ordinate all sterilisation activities, including coordination with providers and suppliers.
  • Model processes and unit’s operations.
  • Write documentation for sterilisation process flow, support equipment validation and provide guidance and feedback.
  • Ensure equipment maintains its validated state.
  • Ensure that all work conducted is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs).
  • Drive the sterilisation training program, knowing safety rules and regulations, and making sure all personal are trained on safe work practices.
  • Seek opportunities for significant, process or product improvements, considering critical quality attributes, critical process parameters, and product performance characteristics.
  • Develop and maintain project timelines and provide updates and feedback to leadership.
  • Data management, trending (including SPC) and reporting of product performance and other business measures.
  • With appropriate training become a subject matter expert in process & product.
  • Service, troubleshoot and solves engineering problems with processes or equipment already in operation.
  • Ensures processes and procedures are in compliance with regulations.
  • Initiate and complete CAPAs and Change Controls in accordance with site procedures.
  • Liaise with key business stakeholders; QA, Manufacturing, Engineering, R&D, Regulatory Affairs and Purchasing to ensure timely completion of activities.
  • Excellent communication / interpersonal skills
  • Proven Technical writing skills with proven capability in providing rationale for equipment and processes.
  • Mentor coach and co-ordinate a team.

 

Minimum Qualifications and Experience:

  • A relevant third level qualification in Engineering/Manufacturing/Science, Mechanical, Electrical, Electromechanical is preferred.
  • Minimum 5 years’ experience in the Engineering/Manufacturing/ Scientific field.
  • Ability to interpret data, discuss findings and resolve complex analytical problems.
  • Recognize adverse trends and emerging issues. Propose and implement solutions to internal and external issues.
  • Strong problem solving.
  • Strong mechanical and electrical ability with computer experience, MS Excel & Word are essential.
  • Computer statistical skills will provide immediate expertise for the trending and reporting of data.
  • Must possess good organizational skills and attention to detail.
  • Demonstrate Leadership qualities are a distinct advantage.
  • Demonstrated flexible and innovative approach to work.
  • Electron beam, Gamma, or other sterilisation technologies experience desirable.
  • Knowledge in ISO 11137 desirable.
  • Travel 15% of time

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.
Hidden
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