Commissioning & Qualification (C&Q) Lead

Team Horizon is seeking a Commissioning & Qualification (C&Q) Lead for a leading pharmaceutical company in South Dublin.
We are seeking a highly experienced C&Q [AREA] Lead to manage and oversee commissioning and qualification activities for the [AREA] scope of a new drug product manufacturing facility. This role is crucial in ensuring that systems, equipment, and facilities comply with cGMP standards and regulatory requirements, and are fit for their intended use.

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:

• Lead the planning, execution, and documentation of C&Q activities for the designated [AREA], including equipment, utilities, facilities, and processes.


• Develop and maintain area-specific C&Q plans, test strategies, and supporting documentation.


• Collaborate with cross-functional teams (Engineering, Operations, Quality, Contractors) to ensure timely and compliant execution of C&Q deliverables.


• Provide subject matter expertise on pharmaceutical standards (e.g., GAMP, ISPE, ICH) and regulatory expectations (e.g., FDA, EMA).


• Review, approve, and ensure completeness of C&Q documentation, including protocols, risk assessments, and summary reports.


• Track and resolve discrepancies, deviations, and change controls related to C&Q activities.


• Drive continuous improvement initiatives to enhance C&Q processes and reduce project risk.


• Any other duties as assigned.

What you need to apply:

• Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related field. 5–10+ years of experience in Commissioning & Qualification within a GMP-regulated environment, preferably in the pharmaceutical or biopharmaceutical sector.


• Proven leadership experience managing C&Q teams or specific project areas. Strong technical knowledge of commissioning, qualification, and validation practices.


• Deep understanding of regulatory guidelines and industry best practices (FDA, EMA, ICH, ISPE, GAMP).


• Experience with digital validation tools (e.g., Kneat, EDMS).


• Excellent communication, leadership, and interpersonal skills. Strong analytical and problem-solving abilities.


• Ability to manage multiple priorities in a fast-paced, dynamic environment.