Are you a CQV Lead with 10+ years of experience in commissioning and qualification activities for pharmaceutical facilities?

If you have the relevant experience, send your CV to karen@jobcontax.com or call Karen on +353 17978720 for a confidential chat.

CQV Lead - BioPharma - Cork

Job Description

Our Client is one of Ireland's leading EPCm consultancies and a global player in the Semiconductor, Pharma and Biotech sectors.

CQV Leads for Upstream, Downstream, Clean Utilities, Black Utilities and HVAC

Manage team of C&Q Engineers on high profile client site throughout the project life cycle.

Strong experience with Validation Master Plan, Commissioning Master Plan, project procedures and commissioning and qualification protocols (SAT/Commissioning, IQ and OQ)

Design Review (DR) process and GMP Risk Assessment (FMEA) experience

Identify the appropriate Commissioning and Qualification strategy to apply on specific project and define the list of activities required

Review and follow-up technical documentation from the early design phase in order to ensure alignment with GMP and CQV requirements

Investigate and resolve technical issues with assistance from engineers and/or suppliers

Ensure site project execution is undertaken in compliance with company guideline, department procedures and safety standards

Be familiar with the Mechanical Completion procedure and Construction scope of work (Walkdown, system acceptance, punch list and follow up)

Schedule preparation and progress review

Organize and review daily activities of other CQV Engineers assigned to the project

Project management principles to coordinate CQV activities and reporting

Contractors and Vendors management and coordination

Final Handover reports to the Client users

The Lead CQV Engineer reports to the department manager / site commissioning manager and is accountable to coordinate CQV resources, deliverables and activities from the validation approach definition, design review, turn-over systems definition and C&Q activities at site.

Requirements

Degree or equivalent in an engineering related discipline

10+ years of experience in commissioning and qualification activities for 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

Proven experience with international pharmaceutical projects

Mentor for junior staff members

Package

Minimum 12-month contract

Pay rate €70 per hour - €90 per hour

Contact

Karen McHugh is the consultant managing this position.

If you are a CQV Specialist interested in roles based in Cork, you can contact Karen by e-mail at karen@jobcontax.com or phone +353-1-7978720 for a confidential chat.

JobContax do not send CVs to clients without candidate permission.

With over 50 years of technical recruitment experience, JobContax is the leading recruiter of CQV Specialists in Cork and Ireland.

Due to the large volume of applications, JobContax may not be able to respond to every individual.

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