Validation Engineer

Recruiter
Siemens
Location
Sudbury, UK
Salary
Competitive
Posted
14 Aug 2019
Closes
05 Sep 2019
Ref
1234994146
Sector
Engineering
Contract Type
Permanent
Hours
Full Time
On behalf of our client, a global manufacturer of medical technology and equipment, I am recruiting for a permanently employed Validation Manager.

The role is based in Sudbury, Sofolk. I am looking for an experienced Validation Manager to lead and inspire the validation team as part of the extended site leadership. You will be managing a team of 3 people.

You will manage and support validation activities across all functions with a key emphasis on providing expertise in all aspects of process, equipment and computer system validation and technical support.

Key Duties:

Core Validation Requirements

Manage and maintain the Site Validation Master Plan and associated Validation Master Tracker in accordance with GMP.

Chair site Validation Review Board

Preparation and execution of validation protocols. Author, review and approve validation, technical documentation and SOPs.

Assisting system owners with impact assessments and identifying qualification/validation requirements.

Carrying out all validation activities on equipment

Regulatory Requirements
Represent the business in customer audits and regulatory inspections to demonstrate that we have compliant systems.
Maintain compliance with Data Integrity Regulations, GAMP standards, 21 CFR Part 11 and applicable regulatory guidelines.

I am looking for candidates with extensive validation experience in medical product manufacturing industries. You should be fluent in cGMP principles, with a thorough understanding of regulatory requirements for EMA ISO13485 and US CFR 820.

You will need a thorough understanding of the principles of validation (e.g. V Model) and have proven leadership skills in leading small to medium-sized teams. I am also interested in candidates with solid project management experience leading small to medium-sized teams in technical projects.

For more information or to apply please make contact at the details attached.

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