Engineering Projects Specialist
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.
- Manage projects at Carlow from scope development, design, build/install and qualify through to handover to operations for key Technical Engineering projects on-site.
- 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 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.
- Documentation completion.
- Risk assessments.
- Closing out corrective action.
- Participate in audits and inspections, proactively highlighting any issues around compliance.
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.
- 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.
This job was originally posted as www.totaljobs.com/job/79161389