CQV Engineer

Arcadis; Athlone; On-site; EUR 90,000 - 130,000; Full time

Job summary

Arcadis Ireland seeks a C&Q (Commissioning & Qualification) Lead with 5+ years in pharma commissioning to own CQV activities for solid dosage projects. You will coordinate interfaces, manage subcontractors, and report progress to the Senior Project Manager to ensure GMP, CSV fundamentals and regulatory expectations are met.

The role is client-side, reporting to the SRV supervisor, with responsibility for commissioning strategy, schedule, quality, safety and compliance throughout the lifecycle.

Qualifications

• Minimum 5+ years’ GMP experience.
• Proven track record of commissioning and qualification involving solid dosage process equipment installation.
• Experience planning and delivering complex commissioning and qualification of systems.
• Excellent stakeholder management and reporting skills.
• Leadership of client teams.
• Strong problem solving and decision-making under programme pressure.
• Strong advocate of health & safety.
• Strong communication skills across organisation levels.
• Detailed understanding of commissioning and qualification and best practice.

Responsibilities

• Develop and own CQV activities aligned to project schedule and GMP requirements.
• Plan and lead system commissioning and qualification of equipment.
• Oversee and coordinate CQV partners and subcontractors.
• Interface with Quality, Manufacturing, Operational Readiness, Engineering, EHS, QC.
• Provide CQV status reporting to Senior Project Manager.
• Turnover activities and ensure successful system handover to CQV and Operations.

Skills

Stakeholder management

Leadership

Communication

GMP awareness

Risk-based mindset

Education

Engineering/Science degree

Job description

This is a C&Q (Commissioning & Qualification) role with responsibility for life cycle qualification documentation. This specific role is for Process Equipment in a solid dosage environment. The SRV ER will work with the Equipment Project Lead to ensure the system is commissioned and qualified as expected. The role is client-side, reporting to the SRV supervisor, and will be accountable for commissioning strategy, schedule, quality, safety, and compliance during the commissioning & qualification lifecycle of the project. Candidates must have minimum 5+ years’ experience in pharma commissioning, proven management of commissioning partners and contractors as well as strong understanding of science and risk-based verification of facilities, utilities and process equipment.

Key Responsibilities

• Develop and own the Commissioning, Qualification & Validation (CQV) activities associated with your project, aligned to project schedule and GMP requirements up to Performance Qualification of all systems and equipment. Act as Client C&Q Lead for the project. Throughout execution; coordinate all commissioning and qualification activities and act as single point of contact for CQV interfaces.
• Plan and lead execution of system commissioning and qualification of equipment in accordance with project schedule and phased release of areas.
• Oversee and coordinate Commissioning Partner and commissioning sub-contractors; manage performance against scope and programme. Commissioning partner responsible for commissioning of utility and facility systems.
• Interface with internal stakeholders including Quality, Manufacturing, Operational Readiness, Engineering, EHS, QC.
• Good knowledge of GMP, validation lifecycle, CSV (computer system validation) fundamentals, and regulatory expectations for qualification documentation
• Provide regular CQV status reporting (commissioning progress, qualification status, open actions, risks) to the Senior Project Manager.
• Own risk management for your project: identify, evaluate and mitigate risks; maintain and report risk registers.
• Collaboration during turnover activities and ensure successful system handover to CQV and Operations including documentation, training and punch list closure.
• Ensure best-practice quality management and documentation for GMP and GEP compliance(CTOP, VTOP, test packs, deviation reports).
• Manage resolution of CQV issues, deviations, and change controls

Experience and Education

• Degree qualification in Engineering, Science, related discipline or relevant experience
• Relevant experience in pharmaceutical and GMP regulated manufacturing environments.

Knowledge

• Minimum 5+ years’ GMP experience, with demonstrable experience.
• Proven track record of commissioning and qualification involving solid dosage process equipment installation.
• Experience planning and delivering complex commissioning and qualification of systems.
• Excellent stakeholder management and reporting skills; able to present to senior leadership and governance forums.
• Leadership of client teams
• Strong problem solving and decision-making under programme pressure.
• Strong advocate and understanding of health & safety
• Strong communication skills across various levels of the organisation
• Detailed understanding of commissioning and qualification and best practice.
• Strong documentation discipline and attention to detail; quality-focused.