Job Description

CQV Lead Role (Midlands – Ireland)   –   Paying up to €90 per hour / €175k per year for the right candidate.

Location: Ireland / Midlands   –   Project: Large scale expansion to a large high quality manufacturing plant.

Suitable candidates must have the following Qualifications Key Competencies:

• Degree or equivalent in an engineering related discipline plus 10+ years experience in commissioning and qualification activities for pharmaceutical facilities on large scale pharmaceutical projects.
• Process Support Lead Solution Prep Experience and Cleaning Experience Essential.
• Strong leadership and team player ability, liaising directly with client and other project key functions.
• Proven experience as manager/leader of C&Q team.
• Strong knowledge of ISPE and ASTM E2500.
• Proven experience with international pharmaceutical projects.
• Proven experience of mentoring junior staff members

Responsibilities:

• 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 the engineering team 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 Team and Clients PM.
• Contractors and Vendors management and coordination.
• Final Handover reports to the Client users.

As the Lead CQV Engineer you will report to the department manager / site commissioning manager and you will be 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.

Contact:  Tom Doyle at kppm, E: tom@kppm.ie | T:086 8205038

or email tom@kppm.ie

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