Process Validation Engineer

• 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

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
• Represent Process Validation during Audits.
• Will undertake any assignment or duty, as required by the business

Your qualification

• 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
• 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

Your competencies

• 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

Your Benefits

• 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

Further Information

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.

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