Validation Lead

Location
London
Salary
Dependent on experience
Posted
13 Feb 2021
Closes
15 Mar 2021
Ref
J5634471
Contact
Debra Fong
Contract Type
Permanent
Hours
Full Time
Are you an experienced Validation Lead looking for a new exciting job opportunity?

We are currently looking for a Validation Lead to join a leading Life Sciences company based in the London area.

As the Validation Lead you will be responsible for overseeing the overall site validation strategy and perform validation activities associated with the manufacturing centre including equipment, facilities, utilities and laboratory systems.

KEY DUTIES AND RESPONSIBILITIES:

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

1. You will be responsible for authoring, executing and reporting validation activities within the framework of cGMP - Annex 11 & 15 and in compliance with the company PQS requirements. You will also be expected to represent validation during internal and external audits and inspections.

2. Within this role, you will also be required to manage multiple validation projects, liaising with the project teams and all associated departments on site relating to the validation objects and ensuring work is completed in a timely manner.

3. As the validation lead, you will also be responsible for writing User Requirement Specifications, Design / Installation / Operational / Performance Qualification protocols and reports for validation purposes as well as run validation project execution DQ/IQ/OQ/PQ in conjunction with relevant stakeholders ensuring timelines are met.

4. Additionally, you will manage third party contractors to support commissioning, start-up and qualification activities and ensure validation testing performed by vendors is complete and accurate.

ROLE REQUIREMENTS:

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

1. Substantial validation experience in an aseptic pharmaceutical or biopharmaceutical manufacturing environment is essential for this position, specifically equipment, utilities and environment validation. A combination of Validation and Engineering / Commissioning experience would be advantageous.

2. Experience of line managing a small team of validation engineers, specialists and a network of external contracted resources is also required as the Validation Lead will be managing a small team.

3. You will also need to have a good level of understanding of utility systems, process instrumentation, automation systems and analytical equipment. Experience of maintaining and enhancing overarching, comprehensive and compliant life-cycle programs for validation of facility environments, utilities and systems.


Key Words: Validation Lead Specialist | Utilities | Facilities | Environment | Temperature Mapping | Pharmaceutical | Life Science | Biopharmaceutical | GMP | Engineering | Commissioning | Quality

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