Process Validation Engineer

at  Olympus KeyMed Group Companies

Your responsibilities

• Responsible for the Site Master Validation Plan, including planning, creation of risk based protocols & reports and executing specific validation activities as well as supporting and moderating validation activities carried out by other Engineers
• Support project teams and serial production, e.g. development projects, continuous improvement, change management etc. with a focus on process validation
• Provide advice and direction, compliant to applicable regulatory standards
• Creation of risk based protocols and review
• Approval of validation documentation created by other team members
• Coaching, mentoring and training to increase overall competence and exchange of knowledge

• Application of statistical methods and verification within validation activitiesRepresent Process Validation during audits, both internal and external

Your qualification

• Minimum of a HNC or above (HND/Degree) in an Engineering discipline is essential
• Previous experience of working in an Engineering or Manufacturing environment
• Process Validation expertise, including planning, creation of protocols, execution and ongoing maintenance of the validated condition
• Ability to interpret drawings
• Computer & IT literacy, including competency with Microsoft Office suite
• Good written & oral communication skills
• Ability to work as part of a team and independently

The role requires you to be on your feet for extended periods of time during your general day to day activities. Some travel may be required to visit subsidiary companies and suppliers.

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 that increases over your length of service
• You will be eligible to receive private medical cover
• Comprehensive company pension scheme
• You will be entitled to an annual health check
• At our HQ, we have a subsidised staff restaurant and free parking
• Other benefits include discounted gym membership, cashback and discounts with major UK retailers, enhanced parental leave and so much more!

• Responsible for the Site Master Validation Plan, including planning, creation of risk based protocols & reports and executing specific validation activities as well as supporting and moderating validation activities carried out by other Engineers
• Support project teams and serial production, e.g. development projects, continuous improvement, change management etc. with a focus on process validation
• Provide advice and direction, compliant to applicable regulatory standards
• Creation of risk based protocols and review
• Approval of validation documentation created by other team members
• Coaching, mentoring and training to increase overall competence and exchange of knowledge
• Application of statistical methods and verification within validation activitiesRepresent Process Validation during audits, both internal and externa