Role Purpose:

  • A new opportunity now exists for a Process Engineer to join the Process Engineering Group at our client’s busy pharmaceutical site in Co. Carlow.
  • The successful candidate will report to the Technical Engineering Manager
  • The new team member will serve as technical support for commercial manufacturing with a particular focus on commercial product processes.
  • The ideal candidate will participate and/or lead cross functional or single function teams including liaising with vendors or above site groups.
  • You will typically have prior related work experience; ideally in manufacturing, preferably GMP Setting but applicants from other appropriate working environments will be considered.
  • Knowledge of process monitoring systems, automation systems, operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial.
  • Previous experience with sterile manufacturing is desired.

 

Core Duties and Responsibilities:

  • Design/Author/Review/Approve/Execute qualification/validation documentation and process development studies in line with the standard approval process
  • Design/Author/Review/Approve/Execute Execution/development of change controls
  • Contribution to Kaizen events as appropriate
  • Technical input into quality notification by authoring/reviewing/approving investigations
  • Execution of equipment/qualification validation programs; including re-qualification and re-validation
  • Support continuous improvement through Lean Six Sigma methodologies
  • Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues
  • Serve as technical engineering representative for internal technical group discussions and represent the company’s technical Operations at global technical forums
  • Drive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made. Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance
  • Work collaboratively to drive a safe and compliant culture on site
  • May be required to perform other duties as assigned

 

Education & Qualifications Required:

  • Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline
  • Preferably Min 2 years experience ideally in manufacturing, preferably GMP Setting
  • Demonstratable experience of leading technical related projects
  • Previous experience with sterile manufacturing is desired, but not essential.
  • Evidence of continuous professional development is desirable
  • Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable but not a necessity.
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
  • Report, standards, policy writing skills required
  • Equipment and process validation
  • Sterile filling processes and equipment
  • Proficiency in Microsoft Office and job-related computer applications required
  • Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner.

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


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Role Details:

Job Title: Process Engineer
Location: Carlow
Type: Contract
Date: June, 2024
Image of recruitment specialist

Discuss with:

Alan Carter
recruitment@prochem.ie
Recruitment Specialist
on +353 56 779 0100
Share:

Role Details:

Job Title: Process Engineer
Location: Carlow
Type: Contract
Date: June, 2024
Image of recruitment specialist

Discuss with:

Alan Carter

recruitment@prochem.ie

Recruitment Specialist

on +353 56 779 0100

Share:

Role Purpose:

  • A new opportunity now exists for a Process Engineer to join the Process Engineering Group at our client’s busy pharmaceutical site in Co. Carlow.
  • The successful candidate will report to the Technical Engineering Manager
  • The new team member will serve as technical support for commercial manufacturing with a particular focus on commercial product processes.
  • The ideal candidate will participate and/or lead cross functional or single function teams including liaising with vendors or above site groups.
  • You will typically have prior related work experience; ideally in manufacturing, preferably GMP Setting but applicants from other appropriate working environments will be considered.
  • Knowledge of process monitoring systems, automation systems, operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial.
  • Previous experience with sterile manufacturing is desired.

 

Core Duties and Responsibilities:

  • Design/Author/Review/Approve/Execute qualification/validation documentation and process development studies in line with the standard approval process
  • Design/Author/Review/Approve/Execute Execution/development of change controls
  • Contribution to Kaizen events as appropriate
  • Technical input into quality notification by authoring/reviewing/approving investigations
  • Execution of equipment/qualification validation programs; including re-qualification and re-validation
  • Support continuous improvement through Lean Six Sigma methodologies
  • Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues
  • Serve as technical engineering representative for internal technical group discussions and represent the company’s technical Operations at global technical forums
  • Drive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made. Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance
  • Work collaboratively to drive a safe and compliant culture on site
  • May be required to perform other duties as assigned

 

Education & Qualifications Required:

  • Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline
  • Preferably Min 2 years experience ideally in manufacturing, preferably GMP Setting
  • Demonstratable experience of leading technical related projects
  • Previous experience with sterile manufacturing is desired, but not essential.
  • Evidence of continuous professional development is desirable
  • Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable but not a necessity.
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
  • Report, standards, policy writing skills required
  • Equipment and process validation
  • Sterile filling processes and equipment
  • Proficiency in Microsoft Office and job-related computer applications required
  • Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner.

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

Image of recruitment specialist

Discuss with:

Alan Carter
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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