Senior Validation Engineer (24 Month Contract)

Validation Engineer

Background:

We are seeking a skilled Validation Engineer to design, documentation and release of Test Method Validation Operating Procedures. This role involves training, and supporting of these procedures through adoption and into maturity, compliant with ISO, PMDA and FDA requirements, related to the manufacture of PTCA catheter products. The engineer will design, scheduling and execute test method validations from incoming inspection, in-process and finished product inspection associated with PTCA catheter products.

Additionally, the engineer will provide early stage consultation to other departments on test method requirements at project proposal stages and support other departments in designing documenting, performing and improving test methods and inspection procedures. The role requires using relevant statistical bases to demonstrate that the test methods are accurate, precise and reliable and participates in the development of new test methods where required to meet these criteria. The engineer will also support other validation activities with subject matter expertise and guidance, reviewing external testing partners methodologies, protocols and reports for compliance with relevant regulatory requirements.

Major Roles & Responsibilities:

.Working as part of a cross-functional project team, the engineer will be responsible for the site test method validation related activities;

– Estimation of validation timelines & resource requirements

– Generate and approve standard operating procedures for test method validation

– Ensuring compliance of test method validation process with ISO, PMDA, FDA regulatory requirements

– Generate and approve test methods Master Validation Plan & Report

– Generate and approve test method validation protocols and reports

– Actively involve in the development of risk assessments (FMEA)

– Co-ordinate and execute validation activities

– Provision of project progress updates to the Site Validation Lead

– Escalate validation related issues and risks in a timely manner

– Perform statistical analysis of validation results for comparison to acceptance criteria

– Train and mentor team members on validation processes and procedures

Knowledge and Skills Required:

Working as part of a cross-functional project team, the engineer will be responsible for the site test method validation related activities;

– Estimation of validation timelines & resource requirements

– Generate and approve standard operating procedures for test method validation

– Ensuring compliance of test method validation process with ISO, PMDA, FDA regulatory requirements

– Generate and approve test methods Master Validation Plan & Report

– Generate and approve test method validation protocols and reports

– Actively involve in the development of risk assessments (FMEA)

– Co-ordinate and execute validation activities

– Provision of project progress updates to the Site Validation Lead

– Escalate validation related issues and risks in a timely manner

– Perform statistical analysis of validation results for comparison to acceptance criteria

– Train and mentor team members on validation processes and procedures

· Qualification and Education requirements:

• A minimum of 5-8 years working in a relevant medical device manufacturing environment
• Relevant third level qualification in science or engineering (Level 8)
• Knowledge of medical device manufacturing from a validation, regulatory, or testing perspective
• Practical experience and good working knowledge of test methods relevant to; catheter based delivery devices, preferably PTCA balloon catheters
• Knowledge of the regulatory framework around medical device validation requirements
• Proven ability to work as part of a multi-disciplinary team in a dynamic environment
• Proven track record of committing to and meeting deadlines
• Effective communicator with all levels of the organisation and interaction with customers
• Excellent analytical, numerical, problem solving skills and attention to detail

Job Type: Contract
Contract length: 24 months

Benefits:

• Bike to work scheme
• Company pension
• Employee assistance program
• On-site parking
• Private dental insurance
• Private medical insurance

Schedule:

• Monday to Friday

Work Location: In person