Validation Engineer

Innopharma Technical Services, part of Innopharma Group, specialises in the training and recruitment of highly skilled, project-ready, Engineers & Scientists to the (Bio) Pharmaceutical and MedTech Manufacturing Sector.

We are supporting a global life sciences client in province of Leinster with the appointment of a Validation Engineer to take ownership of validation for Equipment and Cleaning activities.

About the position:

A Validation Engineer will support several aspects of Validation in the following areas:

• Sterilisation - Autoclaves, SIP of vessels
• Cleaning - Parts Washer and CIP of vessels.
• Isolator (Filling, Sterility & Material Transfer isolators) - HVAC, VHP, E-Beam and Depyrogenation
• systems.
• Controlled Temperature Units (CTU) - Temperature/Humidity Mapping.

Key Responsibilities:

• Design, author, review, approve, and execute qualification/validation documentation, cycle development studies, and change controls in line with the standard approval process.
• Resolve technical issues encountered during study execution and engage with Production,
• Maintenance, and Quality representatives during Cycle Development and Performance
• Qualification activities.
• Provide technical input into quality notifications by authoring, reviewing, and approving investigations, including performing root cause analysis of system failures and substandard performance using standard tools and methods.
• Support continuous improvement through Lean Six Sigma methodologies and serve as the validation representative for cross-functional projects and global technical forums.
• Ensure compliance with Global Policies, Procedures, Guidelines, regulatory requirements, and current Good Manufacturing Practices (cGMP) in all activities, considering GMP impact in decision-making.
• Maintain compliance through documentation completion, risk assessments, closure of corrective actions, participation in audits and inspections, and proactive identification of compliance issues.
• Support regulatory audits and submissions, collaborate to promote a safe and compliant culture in Carlow, and perform other duties as assigned.

Preferred Experience:

• Minimum Level 8 degree in relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification.
• Proven track record of delivering excellence with demonstrated experience leading technical projects and supporting continuous professional development.
• Strong knowledge of equipment and process validation within GMP environments, including CTU equipment qualification, equipment validation lifecycle, periodic validation, and exception/deviation management and change control.
• Expertise in thermal/temperature mapping, thermal mapping equipment, and the ability to analyse and interpret complex data linked to equipment performance and out-of-specification findings.
• Knowledge of sterile fill-finish processes and equipment, including autoclave/SIP sterilisation validation, dry heat sterilisation, isolator qualification, filter validation, container closure validation, cleaning validation, and vial and syringe processing technologies.
• Familiarity with process monitoring systems, automation systems (DeltaV), operational intelligence and data systems (PI System), and proficiency in Microsoft Office and related computer applications.
• Understanding of Irish, European, and international regulatory/code requirements, with strong report writing, standards and policy development skills.
• Excellent communication, presentation, and interpersonal skills with the ability to interface effectively with colleagues at all levels and external customers in a team-oriented environment.

Note:

• Due to the nature of the business, additional duties may be required/assigned from time to time.
• All applicants must be eligible to work in Ireland.