Job Description

CQV / C&Q Site Manger

Large scale Biopharmaceutical Project in Cork

Long term contract.

Hourly Rate up to: €125.00 per hour for the right candidate.

The C&Q Site Manager shall be responsible for the management of a multi-discipline team carrying out CQ project lifecycle 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:

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.

Strong experience as manager/leader of C&Q team.

Strong knowledge of ISPE and ASTM E2500.

Single Use Technology Experience

Long term Contract

Hourly Rate: up to €125.00 per hour for the right candidate

For further information or to apply in strictest confidence please contact:  Tom Doyle at kppm. P: 086 8205038

or email tom@kppm.ie

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