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Senior Process Engineer-Tech Transfer (LOA007207)

Reference:A007207
Location: Carlow
Qualification:Degree
Experience:5-7 Years
Job Type:Permanent
Salary:Not Disclosed
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May be suitable for: Process Engineer

This is a hugely exciting opportunity for an ambitious and experienced Senior Process Engineer – Tech Transfer to play a key role in a dynamic, motivated, high-performing group at an exciting moment for our company's expansion in Ireland. The role is a chance to shape the development of a state-of-the-art facility and holds future opportunities for advancement. You will be actively supported and encouraged to continue their professional development
Why is this a compelling position for a dynamic and ambitious leader in Biopharma to consider?

Reporting to the Technical Engineering Lead, you will lead and participate in activities to deliver on the Tech Engineering requirements needed to support the business at Carlow. This includes but is not limited to: Tech Transfer, Validation programs & strategies, Technical support and process improvement projects, network support & collaboration.
You will collaborate across functions, supporting, coaching and facilitating project sub-teams. Together, this dynamic group will meet the required project schedule milestones, in accordance with the applicable our company standards for Quality and EHS compliance

POSITION RESPONSIBILITIES:

Safety

  • Work collaboratively to drive a safe and compliant culture in Carlow. Collaborate with multiple partners (eg., third parties, vendors, quality, donor sites, Supply chain, IPT) in achieving excellence in technical transfer programmes. Serve as technical engineering representative for internal technical group discussions and represent Technical Engineering Carlow at Global Technical Forums as required

Compliance

  • Required to comply with 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
  • Required to be compliant via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance

Process Engineering & Validation

  • Lead and execute process engineering and validation activities to support the technical transfers as well as sustaining site validation activities such as requalification, annual reviews etc This includes but is not limited to: cycle development, Equipment PQ, PPQ's, Cleaning, PCM, CTU mapping, filter validation

Projects

  • Lead and manage multiple Technical Engineering projects needed to support the business at Carlow. This includes but is not limited to: Process improvements, capital projects and Lean projects across multi-disciplined functions which may also require global and network support and collaboration

Continuous Improvement

  • Manage and deliver on all technical/Validation/Quality Notifications/Change control/Project support within the technical engineering team. Use scientific, product and process understanding as a basis for developing risk-based approaches to investigations and trouble shooting
  • Drive collaboration between group functions and proactively looking for synergies and innovative ways of doing work

Technical Expertise

  • Act as a subject matter expert on (1) Equipment Design & qualification; (2) Assisting in C&Q execution and planning; (3) Process design and validation
  • Act as a liaison with both global engineering services and facilities as well as specialist vendors on process requirements to deliver projects

QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS

  • Considerable experience in a comparable role; would typically have experience operating as a senior professional and adding considerable value to the business. Would have process engineering and/or validation experience in a sterile manufacturing environment and have a proven track record in leading a technical team of engineers / scientists through sustaining operations and technical transfer projects. Experience in leading through change would be an advantage.
  • Experience with facility commissioning and start-up an advantage
  • A strong career history in pharma (ideally aseptic filling) and familiarity with a highly regulated environment
  • Knowledge of and experience in applying Six Sigma and Lean methodologies

Technical

  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
  • In depth knowledge and experience of Sterile filling processes and equipment especially aseptic processing
  • Experience of executing and/or managing through equipment and process validation in a sterile environment
  • Knowledge of QbD/CPV desirable
  • Automation and MES knowledge
  • Proven record in planning and basic project management of a team to deliver on time/schedule and cost

People

  • The passion to expand the future of Carlow
  • A great communicator, decisive decision-maker with a proven ability to deliver excellence
  • Willingness to support the team and a strong focus on delivering excellence.
  • Engage with our business colleagues and learn from them as well as from our own experiences
  • Vendor liaison
  • Effective time management and multi-tasking skills
  • Excellent attention to detail
  • Strong change management skills

Education

  • Degree qualification or equivalent (Science, Engineering, Technical)
  • Green Belt preferable


If you would like further Information you can contact the recruiter directly:

Libby Ryan | Tel: +353 (0) 1 507 9254




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