Exciting opportunities now exist at our client’s site in Carlow for Project Engineers to lead and manage multiple Engineering projects from scope development, design, build/install and qualify through to handover to operations for key Engineering projects on site. 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. The suitable person will typically have prior related project engineering experience; ideally in manufacturing, preferably GMP Setting with process engineering and/or validation experience in a sterile manufacturing environment.
- Manage multiple projects on site from scope development, design, build/install and qualify through to handover to operations for key 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 projects, working and collaborating closely with NPI leads to ensure integration into ongoing Validations and/or Technical transfers.
- Collaborate closely with cross functional teams to establish scope in improvement projects onsite to ramp up to a fully commercial site.
- Be accountable for 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.
- 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.
- 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.
- 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 on site.
- Collaborate with multiple partners (e.g., Company network groups, third parties, vendors, quality, donor sites, supply chain, operations).
- Presentations and reporting out on progress of projects to stakeholder as required.
- Managing vendors for work on site ensuring compliance with safety and permitting requirements for all on site activities.
- May be required to perform other duties as assigned.
Qualifications & Experience:
- Bachelor’s degree or higher preferred; ideally in a Science, Engineering or Other Technical discipline.
- Considerable experience in a comparable role; would typically have experience operating as a senior professional and adding considerable value to the business.
- Would have engineering and/or validation experience in a sterile manufacturing environment and have a proven track record in leading a technical team through sustaining operations and technical transfer projects.
- Experience in leading through change would be an advantage.
- Green Belt preferable.
- 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.
- 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.
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