Process Validation Engineer

OLYMPUS EUROPA SE & CO. KG; Southend-on-Sea; Hybrid; GBP 42,000 - 62,000; Full time

Benefits offered by this job

Private medical cover

Pension scheme

Annual health check with BUPA

Employee Assistance Program

Subsidised staff restaurant

Job summary

KeyMed (Medical & Industrial Equipment) Ltd. (OKM) is seeking a Process Validation Engineer to lead process validation activities in a manufacturing environment.

You will develop the Site Master Validation Plan, create risk-based protocols, and execute validation tasks while supporting other engineers and mentoring colleagues. The role requires understanding of FDA 21 CFR Part 820, ISO 13485:2016, and DOE-based validation methods.

Qualifications

• Degree in engineering with relevant experience.
• 2+ years in engineering/manufacturing.
• Familiarity with FDA/ISO processes preferred.

Responsibilities

• Implement process validation per regulatory standards.
• Develop risk-based validation protocols.
• Train and mentor manufacturing staff.

Skills

2+ years engineering experience

ERP systems

Analytical skills

Team player

Education

Bachelor's degree in Engineering

Tools

DoE

Statistical Analysis

Office software

Job description

Process Validation Engineer

KeyMed (Medical & Industrial Equipment) Ltd. (OKM) | Chief Manufacturing and Supply Officer

A global leader in the medical device and technology industry, for more than 100 years Olympus has focused on making people's lives healthier, safer, and more fulfilling. Our products and solutions help to diagnose, prevent, and treat illnesses, further scientific research and keep people safe. Working in the Engineering team within the Manufacturing organisation as the Process Validation Subject Matter Expert (SME). This position will involve undertaking all aspects of Process Validation in the manufacturing environment, ensuring processes are validated for production use in accordance with relevant regulatory standards. This role will be responsible for the Site Master Validation Plan, including planning, creation of risk based protocols & reports and executing specific validation activities as well as supporting / moderating validation activities carried out by other Engineers. The SME will also be responsible for continuously developing the competence within the manufacturing operation and will deliver training when required.

Key Performance Areas

• Continuous Regulatory Compliance of Process Validation
• Compliance with Health & Safety & Environmental procedures
• Successful completion of mandatory training

Your 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
• Will undertake any assignment or duty, as required by the business
• Degree (Desirable) or HND or HNC in an engineering discipline with relevant experience (Essential)
• 2+ years working in an engineering or manufacturing environment (Essential)
• 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
• Ability to work as part of a team
• Good practical problem solving & analytical skills
• Methodical & good attention to detail
• Able to work in a hybrid setting 60% in our Southend office
• Patient Focus - We put patients at the heart of everything - Integrity - We do the right thing - Innovation - We look for new ways to make things better - Impact - We take accountability and get things done - Empathy - We care for one another and work together
• In addition to a competitive salary, you will receive a generous annual leave entitlement - You will be eligible to receive private medical cover - Comprehensive company pension scheme - You will receive an annual health check with BUPA, funded by us - Employee Assistance Program to support your health, mental and emotional-wellbeing - At our HQ, we have a subsidised staff restaurant and free parking - Other benefits include discounted gym and wellness memberships, cashback and discounts with major UK retailers

We value the diversity of individuals, perspectives, and lifestyles, and prioritise inclusion and mutual respect. We are committed to fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish.