Position
Engineering Specialist (Validation) – Carlow Site – PSC Biotech.
Responsibilities
Design, author, review, approve and execute qualification/validation documentation and cycle development studies in line with the standard approval process.
Design, author, review, approve and execute change control development and execution.
Resolve technical issues encountered during study execution.
Engage with Production, Maintenance and Quality representatives during performance qualification activities.
Provide technical input and author or review investigations for quality notifications.
Perform root cause analysis of system failures using standard tools and methods.
Support continuous improvement through Lean Six Sigma methodologies.
Serve as validation representative for cross‑functional projects and represent the validation team at global technical forums.
Ensure compliance with global policies, procedures and guidelines, regulatory requirements and cGMP in day‑to‑day activities.
Maintain compliance through documentation, risk assessments, corrective action closures, audits and inspections.
Support regulatory audits and submissions as required.
Collaborate to promote a safe and compliant culture in Carlow.
May be required to perform other duties as assigned.
Qualifications
Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification.
Experience operating as an individual contributor in a GMP manufacturing setting.
Knowledge of CTU equipment qualification and thermal mapping equipment.
Experience with exception/deviation management and change control.
Demonstrable experience leading technical projects.
Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence and data systems (Pi System) within a GMP environment.
Evidence of continuous professional development.
Familiarity with Irish, European and International codes, standards and practices.
Analytical ability to interpret complex data and link to equipment performance and out‑of‑spec findings.
Report, standards and policy writing skills.
Experience with equipment and process validation.
Knowledge of sterile fill‑finish processes and equipment.
Proficiency in Microsoft Office and job‑related computer applications.
Excellent communication, presentation and interpersonal skills.
Additional Knowledge
Vial and Syringe Processing Technologies.
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