(15h Left) CQV Engineers

7 days ago

Galway, Ireland Project Delivery Partners Full time

Role Summary:

The CQV Engineer will support the commissioning, qualification, and validation activities for Parts Washers and Autoclaves used in GMP environments. The successful candidate will be responsible for ensuring that these critical cleaning and sterilization systems meet all regulatory and internal requirements for installation, operation, and performance, playing a vital role in supporting manufacturing operations and product quality.

Key Responsibilities:

Develop, review, and execute CQV lifecycle documentation for Parts Washers and Autoclaves, including URS, DQ, IQ, OQ, PQ, and associated risk assessments.

Support and manage the start-up, commissioning, and troubleshooting of new and existing Parts Washers and Autoclaves—including FAT, SAT, and punch-list resolution.

Lead and/or assist with cycle development, worst-case loading studies, and validation of cleaning and sterilization processes.

Write, review, and approve protocols, reports, and SOPs related to cleaning, sterilization, and routine operation of automated washers and autoclaves.

Coordinate with cross-functional teams—including project engineering, quality assurance, manufacturing, and vendors—to ensure timely delivery of CQV milestones.

Perform data analysis, including thermal mapping, biological indicator studies, and review of cleaning validation swab/rinse test results.

Ensure compliance with current Good Manufacturing Practices (cGMP), EU Annex 1, ISO, and other relevant regulatory guidance.

Participate in project meetings, contribute to project scheduling, and support deviation management, change controls, and CAPAs.

Train operations and maintenance personnel on cleaning and sterilization process fundamentals, procedures, and best practices.

Skills & Experience Required:

Degree in Engineering, Life Sciences, or related discipline (or equivalent experience).

Minimum [X] years of CQV experience in the pharmaceutical, biotech, or medical device industry.

Proven experience commissioning, qualifying, and validating automated Parts Washers and Autoclaves in GMP environments.

Strong technical understanding of cleaning validation principles, steam sterilization, and related qualification guidance (e.g., EN285, ISO 17665, 21 CFR Part 11).

Familiarity with calibration, instrumentation, utility systems, and process automation as related to cleaning/sterilization equipment.

Experience writing and executing validation protocols, performing data analysis, and managing deviations/CAPAs.

Strong communication, organizational, and documentation skills.

Ability to work independently and as part of a multidisciplinary project team.

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