Role Headlines
The Validation Lead (Projects) is responsible for planning, executing, and overseeing all validation activities within assigned projects to ensure systems, equipment, processes, and software meet regulatory, quality, and operational requirements. This role acts as the primary validation authority within crossfunctional project teams, ensuring compliance, risk mitigation, and successful project delivery.
About Torbay Pharmaceuticals
At TP we have our own special kind of chemistry. Our heritage spans over 50 years with a track record of manufacturing essential medicines across the UK and beyond. With backing from an investment partner are now forging a new path in the private sector.
We are a growing and ambitious business and with this comes opportunities for our people. At TP, we are going places. A career with us means a career helping save lives. We bring skills of all levels and experiences together; not all of our people begin their working lives in pharma. Together we can make lives better.
About the Role
Reporting into the Validation Manager, you will act as the Validation lead for approved TP projects, including CAPEX, facility changes, and process changes. Working as part of a cross-functional delivery team and leading on validation activity.
First things first - Health & Safety
Every role within our business carries responsibility for:
- Putting Health & Safety first in how you work, making sure your own actions and decisions support a safe working environment
-
Identifying and promptly reporting Health & Safety hazards and incidents
-
Following all Health & Safety procedures and challenging or escalating anything that could present a risk to people, product or site operations.
What you can expect in a Validation Lead (Projects) role at TP:
- Lead validation projects across Capex/PD and others from initiation to completion, including equipment, process, and system validation.
-
Develop and execute validation protocols (IQ/OQ/PQ) for new equipment purchased through CAPEX.
-
Oversee creation and maintenance of validation documentation, including V&V packages.
-
Review and approve test scripts, validation plans, and user acceptance tests
-
Partner with engineering to validate new equipment and systems purchased under CAPEX budgets.
-
Ensure equipment and process qualification aligns with project timelines and budget constraints.
-
Conduct risk assessments for new equipment and processes.
-
Maintain validation master plans for site-level equipment and process validation
-
Support development teams by ensuring product requirements are testable and validated.
-
Guide cross-functional teams (R&D, Quality, Engineering) to ensure validation activities align with product development milestones.
-
Ensure products meet quality and regulatory requirements before market release
-
Manage validation records for audits and regulatory inspections.
-
Coordinate audits of internal validation activities and prepare responses.
-
Evaluate proposed changes to validated systems and determine required validation effort.
-
Mentor junior validation engineers and implementation teams.
-
Assign tasks and coordinate business activities related to validation
This role is primarily based onsite, but hybrid working will be considered, subject to business requirements.
What are we looking for:
-
Degree in Chemistry, Microbiology, Pharmaceutical Sciences, or related discipline, or similar experience.
- Typically 3-5+ years in validation, ideally from highly regulated industries.
-
Proven track record leading validation or CAPEX-related projects
-
Strong knowledge of validation methodologies and quality systems.
-
Understanding of equipment qualification, process validation, and software validation.
-
Familiarity with Agile, HP ALM, and testing methodologies.
-
FDA 21 CFR 11/820
-
GAMP 5
-
EU GMP Annex 1 and Annex 15
-
Strong knowledge of GMP and regulatory frameworks.
- Proven leadership and team management skills.
- Excellent problem-solving and decision-making abilities.
-
Excellent communication and interpersonal skills
-
Ability to build relationships with people across all areas of the business
-
Proactive and positive approach
What we offer in return
At the heart of Torbay, we offer roles and career opportunities on your doorstep that you won't find elsewhere. With defined career pathways, and the chance to move between roles and different departments, we support your career journey at every stage. TP is going places. International expansion means growth and new opportunities.
Our benefits set us apart. With 27 days holiday plus Bank Holidays as standard, group life assurance, pension and more - we reward our people for getting the job done.
