CQV Process Engineer

Role Summary:

• A new vacancy has arisen for the role of an experienced CQV Process Engineer at our client’s state-of-the-art pharmaceutical site in Co. Kildare.
• The Process Engineer provides technical oversight and assurance for commissioning, qualification, and validation (CQV) activities for the capital projects group.
• The role focuses on ensuring that process requirements, GMP principles, and risk-based methodologies are appropriately applied by the delivery team.
• The CQV Process Engineer evaluates, challenges, and guides CQV strategies and execution to ensure systems are compliant, inspection ready, and maintained in a validated state throughout their lifecycle.

Core Duties and Responsibilities:

Accountabilities:

• Providing technical oversight to ensure CQV activities align with GMP, regulatory expectations, and company standards.
• Ensuring process understanding, critical quality attributes (CQAs), and critical process parameters (CPPs) are appropriately considered in system design and qualification strategies.
• Accountable for the application of risk-based principles in defining CQV scope and approach.
• Reviewing and approving CQV strategies, plans, and key lifecycle documentation.
• Ensuring that engineering and qualification activities remain in a state of control and support ongoing compliance and inspection readiness.

Responsibilities

• Provide oversight and technical review of CQV documentation, including commissioning plans, risk assessments, and qualification protocols and reports.
• Evaluate whether process requirements have been effectively translated into GMP-compliant design and qualification approaches.
• Ensure critical aspects impacting product quality and patient safety are identified, justified, and controlled.
• Apply risk-based thinking to assess the adequacy of qualification scope, test coverage, and verification activities.
• Challenge and guide project teams, vendors, and CQV service providers to ensure alignment with best practices and regulatory expectations.
• Monitor execution of CQV activities to ensure adherence to approved procedures and identify deviations from expected standards.
• Review change controls and deviations for technical impact and adequacy of resolution.
• Provide input to design and project reviews to ensure compliance and fitness for intended use.

Minimum Qualifications and Experience:

• Bachelor’s degree in Engineering (Chemical, Mechanical, Electrical or related disciplines); professional certification in validation/CQV is preferred.
• Minimum 5+ years experience in Commissioning / Qualification is preferred.
• Strong understanding of pharmaceutical manufacturing processes and associated CQAs and CPPs.
• Solid knowledge of GMP regulations and industry standards (e.g., EU GMP, FDA, ICH).
• Experience with CQV lifecycle and documentation, with emphasis on review and approval.
• Ability to apply risk-based thinking and challenge technical approaches effectively.
• Strong analytical and problem-solving skills with attention to detail.
• Effective stakeholder management, influencing, and communication skills.
• Ability to identify, assess, and escalate risks and compliance issues.
• High level of accountability with a focus on quality, compliance, and inspection readiness.

Please note, we do not require agency assistance with this role.