CQV Engineer

Dublin
Contract
Full-time

1 month ago

Team Horizon is seeking a CQV Engineer a leading pharmaceutical company in South Dublin.We're looking for a versatile C&Q engineer to assist with early deliverables and ensure efficient processes. This role will initially engage with support from the projects team, transitioning to a more onsite position. The contract is for 12 months with the potential for extension, focusing on enabling works, document creation, and vendor pack reviews, while collaborating with engineering, ETL, quality system owners, and a cross-functional team. Candidates should have diverse exposure, possibly across drug substance, drug product, utilities, or process equipment, highlighting adaptability in large-scale projects.Why you should apply:

This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

Develop and execute commissioning protocols (FAT, SAT, IV, FT) for GMP-regulated systems.
Perform system startup, debugging, and initial testing of facility, process, and utility systems.
Ensure systems are installed and operating per design specifications.
Collaborate with cross-functional teams (Engineering, Manufacturing, Quality) during equipment installation and commissioning.
Review and verify technical documentation (P&IDs, wiring diagrams, datasheets).
Conduct risk assessments and develop test plans for facility and utility systems.
Ensure compliance with GAMP, ISPE guidelines, and regulatory requirements (FDA, EMA).
Redline engineering drawings and participate in system walkdowns.
Prepare and execute C&Q documentation and summary reports.
Support continuous improvement initiatives related to C&Q processes.
Any other duties as assigned.

What you need to apply:

Bachelor’s or Master’s degree in Engineering (Mechanical, Chemical, Biopharmaceutical, or related field).
Minimum 5 years of experience in C&Q within the Life Sciences industry.
Strong knowledge of regulatory guidelines (FDA, EMA, ISPE, GAMP).
Hands-on experience with risk-based qualification and C&Q protocols.
Experience with HVAC systems, black/clean utilities, filling lines, component prep, and temperature-controlled equipment.
Proficient in reviewing/redlining engineering documents.
Familiarity with Data Integrity and Computer System Validation (CSV).
Experience with digital execution tools (e.g., Kneat, EDMS).
Strong problem-solving, communication, and teamwork skills. Experience working on large-scale capital projects is a plus.

Team Horizon

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