Description
Job Purpose:
This role is to 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.
Responsibilities:
- Manage projects at Carlow from scope development, design, build/install and qualify through to handover to operations for key Technical Engineering projects at Carlow.
- 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 for improvement projects at Carlow as we ramp up to a fully commercial site:
- Assisting in C&Q execution planning
- System boundary definition
- System level and component criticality impact assessments
- Use of quality risk management
- User Requirement Specs
- 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 (eg 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 eg 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.
- Drive collaboration between groups within the Technical Engineering function proactively looking for synergies and innovative ways of doing work.
- Constantly assessing systems and processes to see what improvement can be made to work smarter and more efficiently, and compliantly.
- 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 internal 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.
- Documentation completion
- Risk assessments
- Closing out corrective action
- Participate in audits and inspections, proactively highlighting any issues around compliance.
- Work collaboratively to drive a safe and compliant culture in Carlow. Collaborating 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.
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.
- 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.
- Proficiency in Microsoft Office and job-related computer applications required.
- Lean Six Sigma Methodology experience desired.
- Experience in audit preparation and execution desired.
- Having a strong safety ethos.
- Have proven record of process improvement implementation.
- Have a proven record of project management of change in a commercial site.
- Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner.
- Understand the specific responsibilities of all Carlow functions as they relate to one's own department as well as the network governance groups.
- Excellent people management skills.
- Proven record in planning and basic project management of a team to deliver on time/schedule and cost.
- Proven contractor and vendor management.
- Strong influence skills.
- Have shown the ability to effectively manage complex projects across multiple disciplines.
- Demonstrate analytical and systematic problem-solving skills.
- Effective time management and multi-tasking skills.
- Troubleshooting skills.
- Goal/results orientated.
- Excellent attention to detail.
- Self motivated.