Job Type: Contract
Job ID: JO-2205-29491
Consultant: Karen McHugh
Are you a C&Q Engineer with 10+ years of experience in commissioning and qualification activities for pharmaceutical facilities and previous experience as manager/leader of C&Q team?
This is a hybrid role with work from home and site visits to plant in Offaly.
If you have the relevant experience, send your CV to email@example.com or call Karen on +353 17978720 for a confidential chat.
CQV Area Lead - Biopharma Site - Offaly
Our Client is one of Ireland's leading EPCm consultancies and a global player in the Semiconductor, Pharma and Biotech sectors.
Area Lead for Solution Preparation (Media & Buffer) & Cleaning (CIP skids, Autoclave & Washers)
Manage team of C&Q Engineers on high profile client site throughout the project lifecycle.
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 Jacobs 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 to Jacobs and Clients PM
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
€75 - €90 per hour hourly rate dependent on experience
Hybrid role with work from home and site visits
Karen McHugh is the consultant managing this position.
If you are a C&Q Engineer 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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