JobContax Hiring for CQV Area Lead – Biopharma Site Job at Ireland , Ireland Full Time

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.

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

€75 – €90 per hour hourly rate dependent on experience

Hybrid role with work from home and site visits

Contact

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 [email protected] 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 C&Q Engineers in Dublin and Ireland.

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

taglife