Process Project Engineer

• Manage multiple projects on site from scope development, design, build/install and qualify through to handover to operations for key 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 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 on site as they 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.
• 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.
• 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.

• 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.
• 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.
• Have a proven record of project management of change in a commercial site and process improvement implementation.
• Experience in leading through change would be an advantage.
• Experience of executing and/or managing through equipment and process design and validation in a sterile environment.
• Experience in audit preparation and execution desired.
• 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.
• 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.

Tandem Project Management