34465-C&Q Engineer- Dublin Contractor NEW

Purpose

We are seeking a skilled Commissioning & Qualification (C&Q) Engineer to support the startup of a new Drug Product manufacturing facility. This role involves executing commissioning and qualification activities across facilities, utilities, equipment, and systems, ensuring compliance with cGMP and regulatory standards.

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 projectsnd regulatory standards.

Responsibilities:

• 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.

Qualifications

• 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