5 days ago Be among the first 25 applicants
Get AI-powered advice on this job and more exclusive features.
Direct message the job poster from Tandem Project Management Ltd.
ERF CertRP | Talent Solutions Specialist | Sourcing & Developing Life Sciences Talent @ Tandem Project Management
Summary:
Our client, a biopharmaceutical company based in Carlow, is currently seeking a Process Engineer. The successful candidate will lead activities required to support the Tech Transfer process for New Product Introduction to the site. This includes, but is not limited to: Tech Transfer, validation programmes and strategies, technical support, process improvement projects, and collaboration within the wider network. The ideal candidate will work cross-functionally, providing support, coaching, and guidance to project sub-teams.
Responsibilities:
• Work collaboratively to promote a safe and compliant culture. Partner with various stakeholders (e.g. network groups, third parties, vendors, quality, donor sites, supply chain) to drive excellence in technical transfer programmes. Serve as the technical engineering representative in internal technical discussions and represent the team at Global Technical Forums as required.
• Adhere to company policies, procedures, and guidelines, as well as regulatory requirements. Execute current Good Manufacturing Practices (cGMP) in all daily tasks, ensuring all decisions consider GMP and compliance impact.
• Ensure compliance through accurate documentation, timely completion of risk assessments, resolution of corrective actions, and active participation in audits and inspections. Proactively flag any potential compliance concerns.
• Lead and execute process engineering and validation activities in support of technical transfers.
• Manage and lead multiple technical engineering projects, including process improvements, capital projects, and Lean initiatives. These may span across multi-disciplinary teams and require global collaboration. Lead integrated project teams to deliver on project goals and collaborate with cross-functional groups to define scope during the ramp-up to commercial operations.
• Oversee technical deliverables such as validation, quality notifications, change controls, and project support within the technical engineering function. Apply scientific, product, and process knowledge to develop risk-based approaches to investigations and troubleshooting.
• Promote and embed Lean Six Sigma principles and standard work practices within the technical engineering team (e.g. structured root cause analysis, statistical process control, data-driven decision making).
• Encourage collaboration between functional teams, continuously seeking process improvements and efficiencies while maintaining compliance.
• Act as a subject matter expert in Equipment Design, C&Q execution and planning, and Process design and validation.
• Liaise with global engineering services, facilities, and specialist vendors to align process requirements and support project delivery.
• Perform additional duties as assigned.
Qualifications & Experience:
• Degree or equivalent qualification in Science, Engineering, or a related technical discipline is required. Green Belt certification is preferred.
• 8+ years' experience in a similar role, ideally at a senior level, with a strong track record in process engineering and/or validation within sterile manufacturing environments (particularly aseptic filling). Experience leading technical teams through technical transfers, sustaining operations, and organisational change is highly desirable.
• Solid understanding and application of Six Sigma, Lean methodologies, and Quality by Design (QbD) or Continued Process Verification (CPV).
• Comprehensive knowledge of Irish, European, and international regulatory standards, with demonstrated experience executing or managing equipment and process validation in sterile settings, including shipping, filter, and cleaning validation.
• Proficient in automation systems, MES platforms, and Microsoft Office tools, with good working knowledge of job-specific computer applications.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Contract
Job function
* Industries
Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Tandem Project Management Ltd. by 2x
Get notified about new Process Engineer jobs in Carlow, County Carlow, Ireland.
Carlow, County Carlow, Ireland 1 week ago
Carlow, County Carlow, Ireland 1 week ago
Carlow, County Carlow, Ireland 6 days ago
Carlow, County Carlow, Ireland 1 week ago
Carlow, County Carlow, Ireland 3 weeks ago
Kildare, County Kildare, Ireland €65,000.00-€70,000.00 6 days ago
Quality Engineer Medical Device Manufacturing
Kildare, County Kildare, Ireland 1 week ago
Newtown, County Kildare, Ireland €55.00-€65.00 5 days ago
Portlaoise, County Laois, Ireland 1 day ago
External Sales Engineer (Water / Wastewater)
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr