CQV Process Engineer

PROCHEM Engineering

Kildare, Ireland

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.