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Process Validation Engineer
Role Overview
You will own all aspects of process validation within the manufacturing environment, ensuring our processes are fully validated for production use in strict compliance with regulatory standards.
Company Information
Zenopa are partnered with a prominent manufacturer of surgical instruments and endoscopic devices. They collaborate with medical specialists to deliver products and services for less-invasive therapies and preliminary diagnosis. Their culture centres around creating a quality customer experience, delivering outstanding operation, and appreciating their team.
Role Requirements
Take the lead in the creation and execution of the Site Master Validation Plan
Collaborate with project teams and production departments
Offer expert advice on process validation, ensuring compliance with relevant regulatory standards.
Lead the creation of risk-based validation protocols, reviewing and approving validation documentation.
Provide coaching and mentoring to less experienced engineers
Apply statistical tools and techniques within validation activities.
Represent the Process Validation function during both internal and external audits.
Person Specifications
Minimum of HNC or higher in an Engineering discipline (Mechanical, Electrical, Manufacturing, or a related field).
Proven track record in an engineering or manufacturing environment, with deep expertise in process validation. You should have experience in planning, creating, executing, and maintaining validation protocols.
Strong technical skills, including the ability to interpret engineering drawings. Proficiency in Microsoft Office and a strong understanding of statistical methods for process validation are essential.
Excellent written and verbal communication skills, with the ability to clearly articulate complex technical concepts to both technical and non-technical stakeholders.
A proactive and collaborative approach, with the ability to work independently as well as part of a team.
Package
Up to £60,000 salary.
Reimbursement scheme available for relocation costs.
26 days of annual leave plus bank holidays.
Defined contribution pension scheme with employer match up to 12%.
Private medical and dental coverage.
Enhanced parental leave.
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We aim to operate and maintain the following set of core values
