C&Q Engineer

Talentech - C&Q Engineer

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C&Q Engineer

Exciting new role based in Kerry, er are looking for an experienced C&Q Engineer who has experience in developing and executing Commissioning Plans, IQ, OQ, PQ protocols, risk assessments, and summary reports.

The C&Q Engineer is responsible for planning, executing, documenting, and leading commissioning, qualification, and validation activities for GMP facilities, utilities, equipment, and computerized systems within regulated pharmaceutical and biotechnology environments.

Key Responsibilities

Commissioning and qualification activities for facilities, utilities, process equipment, and manufacturing systems.

Develop and execute Commissioning Plans, IQ, OQ, PQ protocols, risk assessments, and summary reports.

Coordinate vendors, contractors, and cross-functional teams during project execution.

Ensure compliance with GMP, GDP, ISPE Baseline Guides, ASTM E2500, and applicable regulatory requirements.

Review and approve engineering and validation documentation.

Troubleshoot commissioning and qualification issues and drive timely resolution.

Support audits, inspections, and regulatory inquiries.

Required Qualifications

Bachelor’s degree in Engineering, Science, or related discipline.

5+ years of C&Q/validation experience within pharmaceutical, biotech, medical device, or life sciences industries.

Strong knowledge of GMP regulations and validation lifecycle principles.

Experience with clean utilities, HVAC, manufacturing equipment, and automation systems.

Excellent technical writing, communication, and stakeholder management skills.

Desirable Experience

Experience with sterile, aseptic, or biologics manufacturing facilities.

Knowledge of computerized systems validation (CSV/CSA).

Project leadership and mentoring experience.

Familiarity with risk-based validation approaches and digital validation tools.

If this sounds like you please click apply or feel free to get in touch by email Cara Keegan @ cmua@ellab.com

Application due

Start date

Start as soon as possible

Work hours

40

Category

Category

Validation Services

Workplace

Ireland

Contact

Follow us

Ellab is an innovative and international company, founded in Denmark in 1949.

We provide validation, monitoring, and calibration solutions for thermal processes in the pharmaceutical, healthcare, and food industries. Our products include data loggers, wired and wireless systems, and software for ensuring compliance with regulatory standards, enhancing process efficiency, and ensuring product safety and quality.

Ellab has offices wordwide, over 750 employees and more than 50 distributors.

Novo Holdings has the majority ownership in Ellab Group. Novo Holdings is a Danish investment company that manages the assets and wealth of the Novo Nordisk Foundation.