Validation Engineer - Medical Devices

MEDASIL SURGICAL LIMITED; Leeds; On-site; GBP 40,000 - 56,000; Full time

Job summary

Medasil Surgical Ltd in Leeds is seeking a Validation Engineer to plan, execute and document validation activities across our manufacturing operations in a regulated environment. You will develop validation strategies for equipment, processes, tooling and software, write protocols, and support audits with cross-functional teams including Engineering, Production and Quality Assurance.

The role combines office-based documentation with on-site validation work on the factory floor, with

Qualifications

• Strong analytical and problem-solving skills.
• Excellent attention to detail and documentation.
• Experience planning, executing and reporting validation activities.

Responsibilities

• Plan, develop and execute validation/verification activities per QMS.
• Prepare and execute IQ, OQ and PQ protocols and reports.
• Develop validation strategies, test methods and acceptance criteria.
• Validate and qualify manufacturing equipment, tooling and processes.
• Maintain traceable validation records and support audits.

Skills

IQ/OQ/PQ protocols

Data analysis

Documentation

Problem solving

Communication

Attention to detail

Cross-functional teamwork

Time management

Tools

Microsoft Excel

Microsoft Word

Job description

Medasil Surgical Ltd is a specialist medical device manufacturer based in Leeds. We manufacture medical devices within a regulated environment, with quality and compliance central to our manufacturing operations. We are seeking a Validation Engineer to join our Technical and Engineering team.

The Role

The Validation Engineer will be responsible for the planning, execution, documentation and maintenance of validation and verification activities across the company’s manufacturing operations.

The role covers the validation and verification of manufacturing equipment, processes, tooling, test methods, software, facilities and associated systems used in the manufacture of medical devices.

The Validation Engineer will work closely with Engineering, Production, Quality Assurance, Regulatory Affairs and other relevant departments to ensure that equipment, processes and systems are appropriately qualified and remain in a validated state throughout their lifecycle.

Key Responsibilities

• Plan, develop and execute validation and verification activities in accordance with approved procedures, validation plans and the company’s Quality Management System.
• Prepare and execute (IQ), (OQ) and (PQ) protocols and reports.
• Develop validation strategies, protocols, test methods, acceptance criteria and sampling plans.
• Validate and qualify manufacturing equipment, tooling and associated processes.
• Work with equipment and processes including injection moulding, extrusion, compression moulding, ovens, washing, assembly, sealing and inspection/test equipment.
• Support the preparation and review of Process FMEAs and other risk assessments.
• Identify Critical Process Parameters (CPPs), Critical Quality Attributes (CQAs) and other characteristics requiring control or verification.
• Provide validation input into engineering and quality change controls and determine requirements for qualification, verification or revalidation.
• Support the introduction and qualification of new equipment, processes, tooling, software and manufacturing technologies.
• Maintain accurate, complete and traceable validation documentation and records.
• Support internal, customer, Notified Body and regulatory audits relating to validation and engineering activities.
• Assist with the preparation and maintenance of the Site Validation Master Plan, validation schedules and validation status documentation.
• Identify opportunities for improvement in validation processes, manufacturing processes and equipment performance.

Experience and Knowledge

Skills and Attributes

The role requires:

• Strong analytical and problem-solving skills.
• Excellent attention to detail.
• The ability to investigate technical problems and identify appropriate root causes.
• Excellent written and verbal communication skills.
• The ability to write clear validation protocols, reports, risk assessments and technical documentation.
• Good understanding of data analysis and the ability to interpret validation and process performance data.
• The ability to work independently and as part of a cross-functional team.
• Good time management and organisational skills.
• The ability to manage multiple validation activities and meet agreed deadlines.
• The ability to adapt to changing priorities and work effectively under time constraints.
• The ability to maintain accurate and traceable validation records.
• The ability to communicate effectively with Engineering, Production, Quality, Regulatory Affairs, suppliers and external contractors.
• The confidence to challenge processes, assumptions and technical conclusions where appropriate and provide evidence-based recommendations.
• Good working knowledge of Microsoft Word and Excel, including using Excel for validation data analysis.
• The ability to work on the manufacturing floor and within controlled/cleanroom environments where required.

Working at Medasil

The Validation Engineer will work as part of the Technical and Engineering team and will have regular interaction with Engineering, Production, Quality Assurance and Regulatory Affairs.

The role involves both office-based technical and documentation work and practical activity within the manufacturing environment. The successful candidate will be expected to work independently on assigned validation projects while maintaining effective communication with relevant teams.