A Project Engineer is required for a biopharmaceutical company in Carlow. The incumbent will lead and manage multiple Technical Engineering projects from scope development, design, build/install and qualify through to handover to operations for key Technical Engineering projects at our client site. This includes but is not limited to Utility and Facility improvements, Reliability centred upgrades and general support to Engineering operations group.
- Manage multiple projects at our client’s site from scope development, design, build/install and qualify through to handover to operations for key Engineering projects at our client’s site.
- Develop project scope, cost and delivery time schedule for projects, working and collaborating closely with Site Engineering Operations team.
- Collaborate closely with cross functional teams to establish scope in improvement projects at our client’s site as we ramp up to a fully commercial site.
- 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.
- The suitable person will typically have prior related project engineering experience; ideally in manufacturing, preferably GMP Setting with Utilities & Facility Project experience.
- Green Belt preferable.
- Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
- Excellent report, standards, policy writing skills required.
- Proficiency in Microsoft Office and job-related computer applications required.
- Lean Six Sigma Methodology experience desired.
- Having a strong safety ethos.
- Have a proven record of project management of change in a commercial site.
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