CQV Engineer

DPS Group Global; Athlone; On-site; EUR 90,000 - 130,000; Full time

Job summary

DPS Group Global is seeking an experienced SRV ER to lead CQV activities for pharma Process Equipment in a solid dosage environment. The role is client-side, reporting to the SRV supervisor, and will oversee commissioning strategy, schedule, quality, safety and compliance across the CQV lifecycle.

Candidates should bring 5+ years of GMP pharma commissioning experience, strong leadership, and a proven ability to manage commissioning partners and contractors to ensure timely, compliant delivery.

Qualifications

• Minimum 5+ years GMP experience in pharma commissioning.
• Experience with solid dosage process equipment installation.
• Proven track record in commissioning and qualification of complex systems.

Responsibilities

• Own CQV activities aligned to project schedule and GMP requirements.
• Coordinate commissioning and qualification with CQV interfaces.
• Plan and lead system commissioning and qualification for equipment.
• Interface with Quality, Manufacturing, EHS, QC.
• Provide CQV status reports to the Senior Project Manager.
• Manage risk, deviations and change controls.
• Ensure documentation and handover to CQV and Operations.

Skills

Leadership

Stakeholder management

Problem solving

Communication

Education

Degree qualification in Engineering or Science

Job description

Role Summary

The SRV ER (Science Risk based Validation, Engineer Responsible) 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

Essential Requirements

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.

Desirable Criteria

Key Competencies

• 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.