Job Type: Contract
Job ID: JO-2301-31825
Consultant: Karen McHugh
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 email@example.com or call Karen on +353 17978720 for a confidential chat.
CQV Lead - Biotech - Cork
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
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
Minimum 12-month contract
Hourly rate €50 - € 62.50
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 firstname.lastname@example.org or phone +35317978720 for a confidential chat.
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