- This role is to lead and manage multiple Technical Engineering projects. 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.
- Manage projects from scope development, design, build/install and qualify through to handover to operations for key Technical Engineering projects.
- Use scientific, product and process understanding as a basis for developing risk-based approaches to investigations and troubleshooting that will feed into future projects.
- Develop project scope, cost and delivery time schedule for all Tech Eng projects, working and collaborating closely with Technical engineering leads to ensure integration into ongoing Validations and/or Technical transfers.
- Collaborating closely with cross functional teams to establish scope in improvement projects at Carlow as we ramp up to a fully commercial site.
- Act as a subject matter expert on: equipment design and qualification; assisting in C&Q execution planning; system boundary definition, system level and component criticality impact assessments, use of quality risk management, User Requirement Specs. and requirements traceability matrices, Document Mgt. Systems, FAT/SAT and C&Q protocol development, project implementation.
- Sponsor and foster lean six sigma and standard work within the technical engineering Team (e.g. Structured Root Cause Analysis, Statistical Process Control, Data driven decision making).
- Drive and support continuous improvement by active participation in projects, system failure investigations and investigation reports, execution/development of change control, and contribution to Kaizen events as appropriate.
- Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.; implement subsequent corrective action through the change management system.
- Integration of Computer Systems Validation activities, in collaboration with Automation/IT partners, into required projects.
- Lead and assist in the development and coaching of Technical Engineering personnel whilst delivering to the site business needs.
- Drive collaboration between groups within the Technical Engineering function proactively looking for synergies and innovative ways of doing work. Constantly assessing our systems and processes to see what improvement we can make to work smarter and more efficiently while all the time being compliant.
- Act as a liaison with both global engineering services and facilities as well as specialist vendors to deliver projects on time and in full as required by the business.
- 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. 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. Collaborate with multiple partners (eg. network groups, 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.
- May be required to perform other duties as assigned.
- 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 design and validation in a sterile environment
- Good shipping/Filter/Cleaning validation knowledge required
- Knowledge of QbD/CPV desirable
- Excellent report, standards, policy writing skills required
- Automation and MES knowledge
- Lean Six Sigma Methodology experience desired
- Experience in audit preparation and execution desired
- Have proven record of process improvement implementation
- Have a proven record of project management of change in a commercial site
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
14 Danville Business Park, Kilkenny, Ireland
+353 56 77 90100