Project Validation Lead

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

This is a fantastic opportunity for a Project Validation Lead to join a leading Pharmaceutical business based in the Hertfordshire area.

As the Project Validation Lead, you will provide specialist technical validation knowledge and leadership experience to manage the Validation of a Filling Line, the facility and utilities associated with the Line and all supporting ancillary equipment and processes.

KEY DUTIES AND RESPONSIBILITIES:

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

1. Plan the activities and resources needed to deliver the project validation requirements and manage the work to ensure compliant delivery in accordance with the program and also provide specialist support to Validation Managers and Specialists and manage implementation of technical solutions in the resolution of issues and mitigation of risk.

2. Application of risk and science based tools to drive execution strategies and support issue resolution.
Responsible for the implementation of commissioning, qualification and validation in coordination with the Quality and Sterility Assurance groups.

3. Ownership of the processes (policies, procedures and document management) relating to validation, ensuring compliance with all applicable regulatory and internal quality standards and industry best practice. Ensure they are continuously improved using a risk-based approach, to eliminate waste and improve effectiveness, whilst continuing to align with industry best practices (i.e. ISPE initiatives) and stakeholder requirements.

4. Integrate with, and interact across, all relevant functions including Engineering, Quality Assurance, Manufacturing and/or Supply Chain to ensure compliant validation service delivery to the assets related to the programme as well as maintain an ongoing dialogue with Validation Management to ensure coordination of activities with site validation requirements and that overall validation resources are effectively deployed.


ROLE REQUIREMENTS:

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

1. Relevant degree qualification in a science or engineering related discipline or equivalent experience within a highly regulated GMP manufacturing environment.

2. You will have recent experience of the Validation of Sterile Filling Operations and experience of Facility/Utility Validation. Any experience in Integrated Filling Lines and validation of Freeze Dryers would be highly advantageous.

3. Experience supporting validation requirements of large capital projects is essential.


Key Words: Validation | Project Validation Lead | Validation Manager | Life Science | Pharmaceutical | Biopharmaceutical | GMP | Manufacturing | Quality | QMS | Compliance | Utilities | Equipment | Cleaning | Laboratory | CSV | Process


Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties 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 professionals and scientists. We look forward to helping you with your next career moves.