Project / Validations Engineer

• Management & Co-ordination of Validation activities (equipment/ process) with internal departments, external contractors & suppliers
• Provide technical assistance to Nelipak Healthcare Packaging Derry Production and Quality Departments in the form of process improvements, quality improvements, cost reduction, safety enhancements, and troubleshooting
• Ensure safe working practices are always adhered to
• Acquire knowledge of Health & Safety procedures, work instructions, and associated documentation
• Comply with all Health & Safety Policies
• Review, preparation & approval of SOPs, qualification protocols, deviations and change control related to validation activities
• Execution of validation protocols for equipment, processes and materials
• Provide input into all project phases from design through to commissioning and qualification execution
• Maintain understanding of latest regulatory requirements for validation in compliance with EU/U.S. regulations
• Review validation documentation from contract vendors
• Initiate and implement change control activities
• Provide Validation expertise to all areas of the facility
• Conduct training in Validation methodologies
• Present validation systems at internal and external audits
• Conduct validation activities in compliance with US and EU regulations
• Conduct developmental runs and Commercialization qualification trial runs
• Writes, conducts, analyses, determines and reports on new or modified equipment capabilities, qualifications (IQ/OQ/PQ), and product validations
• Performs customer related quality activities including PPAP, First Articles and capability studies
• Performs other duties as assigned

• Relevant degree (Engineering or similar) and one to three years’ previous process/manufacturing engineering experience
• Experience of effective project co-ordination
• Data analytics experience
• Proven track record in validation execution
• Lean/Six Sigma Training an advantage
• Strong report writing skills
• Self-directed and results driven team player with excellent communication skills
• Ability to operate cross functionally

Lean/Six Sigma Training an advantage

• Paid Time-Off for Vacation and Sick Days
• Flexible Schedules
• EAP (Employee Assistance Programme)
• Work/Life Balance
• Wellness Programs
• Employee Recognition
• Free onsite parking
• Death in Service
• Learning and development opportunities
• E-Learning and Development opportunities