Process Validation Engineer — Hybrid (UK)

Olympus Corporation; Southend-on-Sea; Hybrid; GBP 40,000 - 56,000; Full time

Benefits offered by this job

Annual leave entitlement

Private medical cover

Pension scheme

Annual health check (BUPA)

Employee Assistance Program

Subsidised staff restaurant

Free parking

Discounted gym memberships

Cashback and retailer discounts

Job summary

Olympus Corporation is seeking a Process Validation Engineer to join our production and development teams in a hybrid setting with 60% in the Southend office. The role focuses on implementing regulatory and quality requirements, leading validation projects, and driving continuous improvement across engineering activities.

The ideal candidate has 2+ years in engineering/manufacturing, strong DoE and statistical analysis skills, and solid experience with ERP systems and cross-functional

Qualifications

• Degree (Desirable) or HND or HNC in an engineering discipline with relevant experience.
• 2+ years working in an engineering or manufacturing environment.
• Process Validation, specifically FDA Quality System Regulation 21CFR Part 820 and ISO 13485:2016 Medical Devices.
• Process Validation planning, creation of protocols, execution and ongoing maintenance of the validated condition.
• Using DoE and Statistical Analysis to support validation activities.
• Use of ERP Systems, including interrogating, creating and updating data
• Ability to Interpret Engineering Drawings
• Computer & IT literacy, familiarity with Office software tools
• Good written & oral communication skills
• Ability to work as part of a team
• Project Management experience
• Good practical problem solving & analytical skills
• Methodical & good attention to detail
• Able to work in a hybrid setting 60% in our Southend office

Responsibilities

• Shall implement and work to all applicable regulatory and quality requirements as stipulated within the KeyMed Quality Manual, Quality Policy, and Quality Objectives.
• Shall implement and work to all applicable Health, Safety and Environmental requirements as stipulated within the HSE Manual, HSE Policies, and HSE Objectives.
• Support project teams and serial production, e.g. Development projects, Continuous Improvement, Change management etc with a focus on process validation
• Supply advice & direction, compliant to applicable regulatory standards, to stakeholders regarding Process Validation
• Creation of risk based protocols and review / approval of validation documentation created by other team members
• Coaching/mentoring/training to increase overall competence and exchange of knowledge. Communication and interaction with specialist departments and managers at various international locations
• Interdisciplinary cooperation with the aim of increasing the efficiency of production, identifying potential for improvement and increasing the quality of engineering activities
• Application of statistical methods and verification within the validation activities
• Represent Process Validation during Audits.
• Will undertake any assignment or duty, as required by the business

Skills

Process Validation

DoE & Stats

Analytical skills

Teamwork

Communication skills

Problem solving

Attention to detail

Project management

IT literacy

Hybrid work mindset

Education

Engineering degree or equivalent (Desirable)

Tools

ERP systems

MS Office

Job description

Olympus Corporation is seeking a Process Validation Engineer to join our production and development teams in a hybrid setting with 60% in the Southend office. The role focuses on implementing regulatory and quality requirements, leading validation projects, and driving continuous improvement across engineering activities.

The ideal candidate has 2+ years in engineering/manufacturing, strong DoE and statistical analysis skills, and solid experience with ERP systems and cross-functional