Biotech C&Q Engineer - Dun Laoghaire, Dublin
Office/Project Location:Dun Laoghaire, Dublin
Employment Type: Contract
Work Location: Hybrid
Pay: €65 - 75 per hour
Experience: 5+ years
Visa: EU passport or Stamp 4 visa required
Our client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoghaire, South Dublin.
The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
This is an excellent opportunity to get experience into Ireland's leading aseptic manufacturing plant.
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 on site projects team, transitioning to a more onsite position.
Role focus is 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.
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.
We plan to have five to six senior area leads, supported by approximately 40 individuals across various sections.
This engineer will play a key role in setting up operations and may transition to utilities or cleanroom HVAC roles.
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.
We are seeking candidates to join our projects from beginning to end, working closely with the operational readiness team.
These hires will represent the manager, overseeing the C&Q efforts across various areas.
They'll handle protocol reviews and approvals, aid in production introductions, and coordinate vendor activities.
Initially, they will serve as area leads, and as part of our expansion, we will be dismantling old setups and establishing new trade and main project cabins.
Requirements
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.
Experience with digital tools like KNEAT is beneficial but not essential.
We're looking for candidates experienced in digital execution for document management who have worked on large-scale projects across different pharmaceutical sectors.
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.
Package
Contract role - Hourly rate €65 - €75 per hour
Minimum 12 month contract with the possibility of an extension.
Onsite expectations: Adaptable to a hybrid work model - able to work remotely but ready to be onsite quickly when needed.
Please note the roles will transition into onsite roles.