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Process Validation Engineer

Medical Devices
Southend-on-Sea
£55,000 - £60,000

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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    Further Details/Cover Note

    Locations

    Basildon
    Benfleet
    Bexley
    Bishop's Stortford
    Brentwood
    Camberwell
    Chelmsford
    Chigwell
    Clacton-on-Sea
    Colchester
    Dagenham
    Dartford
    Deptford
    East London
    Gravesend
    Grays
    Greenwich
    Harlow
    Harwich
    Hornchurch
    Ilford
    Lewisham
    Leyton
    Loughton
    Maidstone
    Medway
    Rayleigh
    Romford
    Sidcup
    South East London
    Southend-on-sea
    Stratford
    Sudbury
    Tonbridge
    Upminster
    Walthamstow
    Wickford
    Date Updated
    19 Mar 2025
    Job reference
    74237
    Categories
    Full Time
    Permanent
    Take Experience
    Apply for this role
    Why Zenopa?

    We aim to operate and maintain the following set of core values

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    01

    In house, contracting department.

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    02

    We liaise on your behalf

    Required equipment, e.g. cars, laptops, mobiles, we negotiate with the employer source and manage these on your behalf.

    03

    Solid Industry Relationships

    Our recruitment teams have built relationships with some of the UK’s most prestigious pharmaceutical companies

    04

    High Success Rate

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    05

    Systems that work for you

    As an ISO 9000 organisation we have fully defined systems that are regularly audited. You can be assured we consistently following processes that deliver for all.