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Process Engineering Specialist

3 weeks ago

The Municipal District of Carlow, Ireland beBee Careers Full time

About this role

We are seeking a highly skilled Process Engineering Specialist to lead and execute process engineering and validation activities to support the technical transfers.

Key Responsibilities:
  • Drive a safe and compliant culture through collaborative work with colleagues.
  • Represent Technical Engineering at Global Technical Forums as required, serving as a technical engineering representative for internal discussions.
Requirements:
  • Comply with Global Policies, Procedures and Guidelines, regulatory requirements, and execute current Good Manufacturing Practices (cGMP) in daily activities.
  • Ensure compliance via documentation completion, risk assessments, closing out corrective action, participating in audits and inspections, and highlighting any issues around compliance.
Main Responsibilities:
  • Lead and execute process engineering and validation activities to support technical transfers.
  • Manage multiple Technical Engineering projects needed to support the business.
Additional Responsibilities:
  • Deliver on all technical/Validation/Quality Notification/Change control/Project support within the Technical Engineering team.
  • Use scientific, product, and process understanding to develop risk-based approaches to investigations and troubleshooting.
Technical Expertise:
  • Act as a subject matter expert on Equipment Design, C&Q execution and planning, Process design and validation.
  • Liaise with global engineering services, facilities, and specialist vendors on process requirements to deliver projects.
Qualifications, Skills and Education Required:
  • Significant experience in a comparable role; would typically have experience operating as a senior professional and adding considerable value to the business.
  • A strong career history in pharma (ideally aseptic filling) and familiarity with a highly regulated environment.
  • An innovative thinker with excellent decision-making and problem-solving skills.
Vendor Liaison:
  • Self-motivated and flexible approach.
  • Effective time management and multi-tasking skills.
  • Excellent attention to detail.
Education:
  • Degree qualification or equivalent (Science, Engineering, Technical).
  • Green Belt preferable.

Reporting to: Technical Engineering Lead