Are you a CQV Lead with 8+ years of experience in commissioning and qualification activities for pharmaceutical facilities/projects?

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 - Biotech - Cork

Job Description

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

The Lead CQV Engineer is accountable to coordinate CQV resources, deliverables and activities from the validation approach definition, design review, turn-over systems definition, C&Q activities at site for multiple concurrent projects.

Manage small team of C&Q Engineers on a client site, on multiple concurrent minor/medium size projects, throughout the project lifecycle, as part of the Overall Engineering Service Provider Team.

Produce estimates for C&Q activities for each project and ensuring adherence to these estimates

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

Design Review (DR) process and GMP Risk Assessment experience

Identify the appropriate Commissioning and Qualification strategy to apply on specific projects 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 Jacobs engineers and/or suppliers

Ensure site project execution is undertaken in compliance with site procedures and safety standards

Be familiar with Mechanical/E&I Completion procedure and Construction scopes 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 projects

Project management principles to coordinate CQV activities and reporting to Jacobs and Clients PM

Change Management activities during project lifecycle

Production and execution of all types of CQV documents

Final Handover reports to the Client users

Hands on approach required

Requirements

Degree or equivalent in an engineering related discipline

8+ years of experience in commissioning and qualification activities for pharmaceutical facilities/projects

Strong leadership and team player ability, liaising directly with client and other project key functions

Previous experience as manager/leader of C&Q team preferred

Strong knowledge of ISPE and ASTM E2500

Mentor for junior staff members

Package

Minimum 12-month contract

Hourly rate €50 - € 62.50

Contact

Karen McHugh is the consultant managing this position.

If you are a CQV Lead interested in roles based in Dublin you can contact Karen by e-mail at karen@jobcontax.com or phone +35317978720 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 Leads in Dublin and Ireland.

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