Job Type: Contract
Job ID: JO-2301-31581
Consultant: Karen McHugh
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 firstname.lastname@example.org or call Karen on +353 17978720 for a confidential chat.
CQV Lead - BioPharma - Cork
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.
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
Minimum 12-month contract
Pay rate €70 per hour - €90 per hour
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 email@example.com or phone +353-1-7978720 for a confidential chat.
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