Job Description
CQV Area Lead
Location: Tullamore Co.Offaly
Rate: Up to €90 euro per hour for the right candidate.
Project: Biopharma Plant
Long term contract: To end of December 2023.
Area Lead for Solution Preparation (Media & Buffer) & Cleaning (CIP skids, Autoclave & Washers)
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 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 Company and Clients PM.
- Contractors and Vendors management and coordination.
- Final Handover reports to the Client users.
The Area 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.
Qualifications Key Competencies required for the role include:
- 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.
Contact Tom Doyle at kppm: P: 086 8205038 | E: tom@kppm.ie
or email tom@kppm.ie
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