Validation Engineer: Medical Devices, NPI & Tech Transfer

LennTech Search; Dublin; On-site; EUR 65,000 - 90,000; Full time

Job summary

LennTech is seeking a Validation Engineer to support the introduction, transfer and manufacture of medical device products in a fast-paced setting. You will plan, execute and document validation activities for manufacturing processes, equipment, facilities and test methods, ensuring compliance with regulatory and quality requirements.

You will lead IQ/OQ/PQ activities, develop validation strategies, and collaborate with Quality, Engineering, Manufacturing and R&D teams.

Qualifications

• Engineering or scientific qualification or equivalent experience.
• Experience in validation within a medical device, pharmaceutical or other regulated manufacturing environment.
• Experience with process validation and/or equipment qualification.
• Knowledge of IQ/OQ/PQ and risk-based validation.
• Good understanding of ISO 13485 and Quality Management Systems.
• Strong technical writing, analytical and problem-solving skills.

Responsibilities

• Develop and execute validation and qualification protocols and reports.
• Lead/support IQ, OQ, PQ and process validation activities.
• Support new product introduction (NPI) and customer technology transfer projects.
• Develop risk-based validation strategies, sampling plans and acceptance criteria.
• Support equipment, process, cleaning, packaging or other special-process validation where applicable.
• Analyse validation data and provide scientifically justified conclusions.
• Manage validation deviations, investigations, CAPAs and change controls.
• Maintain the validated state and support revalidation activities.
• Work closely with Quality, Engineering, Manufacturing, R&D and customer teams.
• Provide technical validation support during customer and regulatory audits.
• Ensure validation activities comply with ISO 13485, company procedures and applicable customer/regulatory requirements.

Skills

IQ/OQ/PQ

Risk-based validation

ISO 13485

Technical writing

Problem-solving

Cross-functional teamwork

Manufacturing experience

MSA/Gauge R&R

Statistical tools

NPI & tech transfer

Education

Engineering degree or equivalent

Tools

Minitab

Job description

LennTech is seeking a Validation Engineer to support the introduction, transfer and manufacture of medical device products in a fast-paced setting. You will plan, execute and document validation activities for manufacturing processes, equipment, facilities and test methods, ensuring compliance with regulatory and quality requirements.

You will lead IQ/OQ/PQ activities, develop validation strategies, and collaborate with Quality, Engineering, Manufacturing and R&D teams.