Applications must be written in english.
We are currently seeking and experienced C&Q Site Manager to join one of Ireland's leading EPCm consultancies and a global player in the Semiconductor, Pharma and Biotech sectors.
The C&Q Site Manager shall be responsible for the management of a multi-discipline team carrying out CQ project life cycle related activities for a biotech facility from Design through to End User Handover
Responsibilities:
Oversight and implementation of the client C&Q Program, ensuring a quality delivery- Ensure that process equipment qualification activities are completed in line with Site procedures, cGMP and best practices.
- Overview of protocol development and execution activities for the Commissioning & Qualification aspects.
- Planning, scheduling, and coordination of vendors (FAT, SAT& IOQs)
- Provide technical oversight and guidance to the C&Q team.
- Safety oversight of the C&Q team, in collaboration with the project safety team.
- Oversight of Change Management activities during project lifecycle
- Summary Report writing/ metrics (status/forecasting)
- Provide leadership to the C&Q team and on-site development of team members in delivery approach
- Forecast needs from various stakeholders and ensure timely intervention to meet schedule
- Generate and maintain C&Q schedules to plan and track activities over the C&Q life-cycle.
- Interfacing with Client representatives on project team, Engineering Team, Quality team and End Users during the different project phases
- The C&Q Site Manager reports to the Site Project Manager and C&Q Project Manager and is accountable to coordinate C&Q resources, deliverables and activities from the qualification approach definition, design qualification, turn-over systems definition till C&Q activities at site (IOQ complete).
Requirements:
- Degree or equivalent in an engineering related discipline
- 7 - 10 years of experience in commissioning and qualification activities for biotech pharmaceutical facilities is preferred
- Strong leadership and team player ability, liaising directly with client and other project key functions
- Previous experience as manager/leader of C&Q team
- Strong knowledge of ISPE and ASTM E2500
- Single Use Technology Experience
Package:
- Minimum 12-month contract
- €90 - €110 per hour hourly rate dependent on experience
- Hybrid role with work from home and site visits
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