Title: CQV API Project Lead
Location: County Tipperary
Type: 12-Month Contract
Salary: DOE
Ref: DES - 1218
Overview
We are seeking an experienced CQV API Project Lead to oversee a multi-discipline Commissioning & Qualification (C&Q) team delivering a large-scale API pharmaceutical facility project from design through to end-user handover.
The successful candidate will provide leadership, technical oversight, and coordination across all C&Q lifecycle activities, ensuring safe, compliant, and high-quality delivery aligned with cGMP, ISPE, and ASTM E2500 standards.
This role requires a strong background in API pharmaceutical commissioning and qualification, with proven experience leading teams in complex capital projects within regulated environments.
Responsibilities
- Lead and manage the site C&Q programme across the full project lifecycle (design through to handover)
- Ensure all commissioning and qualification activities are executed in line with site procedures, cGMP, and industry best practices
- Oversee development and execution of C&Q protocols including IQ/OQ activities
- Plan, schedule, and coordinate vendor activities including FAT, SAT, and IOQ execution
- Provide technical leadership and guidance to the C&Q team
- Ensure safety oversight of all C&Q activities in collaboration with the project safety team
- Manage change control processes throughout the project lifecycle
- Develop and maintain C&Q schedules, tracking progress, forecasting, and reporting metrics
- Produce summary reports, status updates, and performance metrics for stakeholders
- Interface with engineering, quality, client representatives, and end users across all project phases
- Lead and mentor C&Q team members, supporting capability development and delivery performance
- Forecast resource and project needs, ensuring timely interventions to meet schedule requirements
Requirements
- Degree or equivalent qualification in an engineering-related discipline
- 15+ years’ experience in commissioning and qualification within API pharmaceutical facilities
- Proven experience leading and managing C&Q teams on large-scale pharma projects
- Strong knowledge of ISPE guidelines and ASTM E2500 approach
- Experience with KNEAT and DeltaV systems
- Strong leadership, communication, and stakeholder management skills
- Ability to work collaboratively across multi-discipline project teams in a regulated environment
- Demonstrated experience in lifecycle C&Q delivery from design through to system handover
*Only candidates with a valid work visa for Ireland or an EU passport will be considered.
To discuss this role in more detail, contact Corné at 0949316002 or
[email protected] for a confidential discussion.
IND004
Experience:
- API pharmaceutical facilities: 10 years (preferred)
Location:
- Tipperary, County Tipperary (preferred)
Work Location: In person
