Senior Validation Engineer

Independent Solutions; Munster; Hybrid; EUR 70,000 - 100,000; Full time

Benefits offered by this job

Hybrid work arrangement

12-month contract

Job summary

Independent Solutions in Limerick, Ireland, seeks a Senior Validation Engineer to lead validation activities for new production lines and NPI in a regulated medical device environment. The role is a 12-month contract with a hybrid arrangement requiring a minimum of 3 days onsite per week.

You will develop master plans, validate protocols, and ensure compliance with quality systems while collaborating with Quality, Engineering and Manufacturing to drive improvements and on-time delivery.

Qualifications

• Minimum 5 years' medical device validation experience.

Responsibilities

• Provide technical expertise across validation activities including equipment, facilities, cleaning, test methods, reagents and environmental validation.
• Support validation activities for new lines, new equipment and new products.
• Prepare, review and approve Validation Master Plans, protocols, reports and summary documentation.
• Ensure validation activities comply with applicable quality systems, validation procedures and regulatory requirements.
• Maintain accurate validation records and ensure validation documentation is current.
• Identify, investigate and resolve technical and operational validation issues.
• Support audits and ensure validation activities remain compliant and inspection-ready.
• Work closely with Quality, Engineering, Manufacturing and other cross-functional teams.
• Drive continuous improvement and identify opportunities to improve validation processes.
• Provide technical guidance and support to project and validation teams.
• Ensure validation activities are completed accurately and within agreed timelines.

Skills

Validation experience

Cross-functional collaboration

Regulatory compliance

Problem solving

Strong communication

Job description

Working Arrangement: Hybrid – minimum 3 days onsite per week

Contract: Initial 12 Month Contract (Potential to extend)

Industry: Medical Device

We are currently seeking Senior Validation Engineers to support validation activities associated with new production lines and new product introduction (NPI) within a regulated medical device environment.

Key Responsibilities

• Provide technical expertise across validation activities including equipment, facilities, cleaning, test methods, reagents and environmental validation.
• Support validation activities for new lines, new equipment and new products.
• Prepare, review and approve Validation Master Plans, protocols, reports and summary documentation.
• Ensure validation activities comply with applicable quality systems, validation procedures and regulatory requirements.
• Maintain accurate validation records and ensure validation documentation is current.
• Identify, investigate and resolve technical and operational validation issues.
• Support audits and ensure validation activities remain compliant and inspection-ready.
• Work closely with Quality, Engineering, Manufacturing and other cross-functional teams.
• Drive continuous improvement and identify opportunities to improve validation processes.
• Provide technical guidance and support to project and validation teams.
• Ensure validation activities are completed accurately and within agreed timelines.

Requirements

• Minimum 5 years' medical device validation experience.
• Strong experience with validation within a regulated environment.
• Experience with new line, new equipment and/or NPI validation is highly desirable.
• Good understanding of validation documentation, quality systems and compliance requirements.
• Strong technical problem-solving and communication skills.
• Experience working with cross-functional teams.
• Ability to work minimum 3 days onsite per week in Limerick.

12-month contract | Hybrid | Limerick | Medical Device