Qualification & Validation Engineer

Qualification & Validation Engineer

Our client who is a leading pharmaceutical company is looking for a Qualification & Validation Engineer. If you have worked on Process Performance Qualifications then this is the job for you !!! This is a hybrid positon and you can be based 2 days on site 

The Role

• Author, review, and execute PPQ protocols and reports in alignment with global standards and regulatory expectations.
• Define PPQ strategy including batch numbers, sampling plans, acceptance criteria, and statistical approaches.
• Contribute to the development and maintenance of the Process Validation Master Plan (PVMP).
• Support lifecycle management changes requiring PPQ, including technology transfers and post-approval changes.
• Develop / Participate in risk assessments to evaluate process risks and define appropriate control strategies.
• Apply risk-based approaches to PPQ study design, sampling strategies, and acceptance criteria justification.
• Ensure timely closure of PPQ-related deviations and CAPAs prior to and following PPQ execution.
• Maintain accurate and audit-ready documentation throughout the validation lifecycle.
• Work closely with MSAT, Manufacturing Operations, Quality Control, and Quality Assurance to ensure alignment on PPQ strategy, execution, and outcomes.
• Ensure all PPQ activities are conducted in compliance with applicable regulations and guidelines.
• Support regulatory inspections and internal audits by providing PPQ documentation and technical expertise.
• Provide training and technical guidance to operations personnel, validation associates, and cross-functional team members involved in PPQ activities.
• Design and execute Continued Process Verification (CPV) programs

Requirements

• Degree in science (e.g. Chemistry, Microbiology or IT preferred) or Engineering (Chemical/Mech/Elec) discipline
• Minimum 3–5 years of experience in pharmaceutical manufacturing, process validation, or quality assurance in a regulated GMP environment
• Demonstrated hands-on experience in Process Performance Qualification (PPQ) design, execution, and reporting
• Proven track record of authoring and reviewing validation documentation (protocols, reports, deviations, change controls)

Please call Louise Mulligan today for further information on 0949003979 or email: lmulligan@careerwise.ie

CareerWise Recruitment (In Search of Excellence)

Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. 

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.

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