Validation Engineer

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

Department: Engineering / Technical Operations

Reports to: Validation Manager / Engineering Manager

Role Overview

LennTech are seeking a Validation Engineer to support the introduction, transfer and manufacture of medical device products within a fast-paced environment.

The role will be responsible for planning, executing and documenting validation activities for manufacturing processes, equipment, facilities and test methods, while ensuring compliance with applicable regulatory and quality requirements.

Key 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 and 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.

Requirements

• 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.
• Ability to manage multiple projects and work effectively with cross-functional teams.
• Previous manufacturing experience.
• Experience with NPI and technology transfer.
• Knowledge of ISO 14971.
• Experience with MSA/Gauge R&R and statistical tools such as Minitab.
• Experience with sterilisation, cleaning, packaging or other special-process validation.