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Process Engineer

4 months ago

Dublin, Dublin City, Ireland Life Science Recruitment Full time
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Process Engineer - Commercial Manufacturing

Process Engineer – Commercial Manufacturing
AMC 21444
Contract – 11 months
Carlow

We're currently recruiting for an exciting opportunity with a Biopharmaceutical organization based in Carlow. This is an excellent opportunity to join a rapidly expanding biopharmaceutical who are changing lives daily.

This role will be responsible for providing technical support for commercial manufacturing with a focus on commercial product processes.

The successful candidate will participate in and lead teams across various levels including liaising with vendors and above site groups. You will have 2+ years GMP experience as well as a relevant degree.

Ideally you will have manufacturing experience in a GMP environment including knowledge of process monitoring systems, automation systems, operational intelligence and data systems. Previous experience with sterile manufacturing is a distinct advantage.

Key Responsibilities:

  • Design/Author/Review/Approve/Execute qualification/validation documentation and process development studies in line with the standard approval process
  • Design/Author/Review/Approve/ExecuteExecution/developmentof change controls
  • Contribution to Kaizen events as appropriate
  • Technical input into quality notification byauthoring/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 technical Operations Carlow 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

Process Engineer – Commercial Manufacturing
AMC 21444
Contract – 11 months
Carlow

We're currently recruiting for an exciting opportunity with a Biopharmaceutical organization based in Carlow. This is an excellent opportunity to join a rapidly expanding biopharmaceutical who are changing lives daily.

This role will be responsible for providing technical support for commercial manufacturing with a focus on commercial product processes.

The successful candidate will participate in and lead teams across various levels including liaising with vendors and above site groups. You will have 2+ years GMP experience as well as a relevant degree.

Ideally you will have manufacturing experience in a GMP environment including knowledge of process monitoring systems, automation systems, operational intelligence and data systems. Previous experience with sterile manufacturing is a distinct advantage.

Key Responsibilities:

  • Design/Author/Review/Approve/Execute qualification/validation documentation and process development studies in line with the standard approval process
  • Design/Author/Review/Approve/ExecuteExecution/developmentof change controls
  • Contribution to Kaizen events as appropriate
  • Technical input into quality notification byauthoring/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 technical Operations Carlow 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
Qualifications:
  • Relevant Bachelors degree with 2+ years experience in manufacturing in a GMP setting
Required:
  • Demonstratable experience of leading technical related projects
  • 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 experience
Desired
  • Previous experience with sterile manufacturing is desired, but not essential.
  • 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
If you are interested in this posting please feel free to contact Angela McCauley on or [email protected] for further information or submit your CV now.

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