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Validation Manager

Maidstone, KentPermanent
Experience Dependent
Job Reference: J5633581
Updated On: 31/07/2020
Status: Open to Applications
Hyper Recruitment Solutions
Sectors: Biotechnology, Medical Device, Contract Manufacturing Organisation, Contract Testing Organisation, Bioprocessing

Skills: Engineering - Commisioning, Engineering - Facilities, Engineering - Maintenance, Engineering - Projects, Engineering - Quality, Engineering - Validation Perm, Engineering - Pharmaceutical, Engineering - Medical Devices, Engineering - Controls, Engineering - Engineering Manager, Engineering - Calibration

Job Information

Role Overview

Are you an experienced Validation Manager looking for a new exciting job opportunity?

We are currently looking for a Validation Manager to join a leading diagnostics company based in the Kent area.

As the Validation Manager you will direct the development and implementation of validation test procedures to ensure product(s) meet appropriate regulatory agency validation requirements, internal company standards and industry current practices. You will oversee and review validation area processes and procedures, making recommendations for changes and/or improvements.

Key Duties and Responsibilities

Your duties as the Validation Manager will be varied however the key duties and responsibilities are as follows:

1. You will manage the day to day activities of the Validation team and development and performance of direct reports on a day to day basis, interacting with many different functions and levels within the organisation.

2. You will be responsible for coordinating and supporting validation activities of the new build facility and perform validation projects activities for all facilities, equipment and processes operated in compliance with Current Good Manufacturing Practice (cGMP) requirements whilst maintaining best practices for departmental procedures to ensure effectiveness

3. As Validation Manager, you will also prepare, execute and report validation protocols, rationalise validation documentation to ease routine validation activities and liaise with engineering, quality assurance and user departments to ensure that validation is conducted in a timely manner with minimal disruption to production.

4. You will attend meetings both external and internal, representing the department in a professional manner, participate in audits by customers and regulatory authorities and also support Environmental Management System (EMS) activities and compliance per ISO14001.

Role Requirements

To be successful in your application to this exciting opportunity as the Validation Manager we are looking to identify the following on your profile and past history:

1. A relevant degree in Chemistry, Biology or Engineering and experience working to cGMP including validation requirements for cGMP applications.

2. You need to have an understanding of ISO 9001 and ISO 13485 quality systems as well as cleaning validation knowledge. You will also need to have experience in writing validation related procedures including Validation Master Plan (VMP) and write validation reports.

3. General knowledge of sterilization validation, water system validation, HVAC system validation, temperature mapping, and data integrity are also required for this position.
Debra Fong
Your Recruitment ConsultantDebra
DisclaimerHyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.