Job Description

CQV Project Manager

Location: Tullamore Co.Offaly

Rate: Up to €110 euro per hour for the right candidate.

Project: Biopharma Plant

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).

Qualifications Key Competencies essential for the role include:

• Degree or equivalent in an engineering related discipline.
• 15+ years of experience in commissioning and qualification activities for Biotech pharmaceutical facilities.
• 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

Contact Tom Doyle at kppm:  P: 086 8205038 | E: tom@kppm.ie

or email tom@kppm.ie

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