Job Title: Periodic Qualification Engineer
Location: Waterford
Work Model: Hybrid (minimum 3 days on-site per week)
Contract Type: CFS
Role Overview
The Periodic Qualification Engineer supports the site requalification programme, ensuring ongoing validation, compliance, and regulatory readiness of equipment, systems, and processes across the manufacturing site.
Key Responsibilities
Design, execute, and report periodic qualification and requalification activities for equipment, systems, and processes
Ensure compliance with cGMP, Health & Safety, environmental, and applicable regulatory standards
Provide technical interpretation of US FDA and EU validation requirements, including aseptic processing, lyophilisation, sterilisation, and depyrogenation
Maintain validated status of equipment and systems at all times
Support site change control processes
Participate in external regulatory inspections
Experience
3–5 years’ experience in a healthcare manufacturing environment, preferably pharmaceutical
Technical Skills
Strong knowledge of pharmaceutical manufacturing facilities and validation principles
Experience troubleshooting validation issues during projects and process development
Knowledge of GAMP and ISPE Baseline Guides
Familiarity with steam and dry heat validation standards (AAMI/ANSI, PDA, ISO)
Solid understanding of quality management systems, compliance regulations, KPIs, and project execution
Proficiency in MS Project and SPC tools is an advantage
Strong communication skills at all levels
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