Principal Validation Specialist
1 week ago
We are seeking an accomplished professional to develop and deliver validation packages for bespoke automated equipment within a fast-paced, high-technology company.
This role focuses on supporting FDA-regulated manufacturing customers by ensuring compliance with validation standards throughout all project stages, from proposal to final delivery.
Main Responsibilities:- Develop, review, and approve validation plans.
- Design and implement user requirements specifications, functional design specifications, hardware design specifications, and software design specifications.
- Create commissioning documentation and oversee factory acceptance test and site acceptance test documentation.
- Develop and review qualification test data, providing technical input to resolve discrepancies and deviations.
Qualifications & Experience:
- Bachelor's degree in Science, Engineering, or a related discipline.
- Minimum of 3 years' experience in a validation role within a regulated environment.
Main Skills & Abilities:
- Proven experience in developing validation documentation for the pharmaceutical and medical device industries.
- Strong organisational skills with a proactive and solutions-focused mindset.
- Ability to multitask and manage multiple projects effectively.
- Excellent communication and stakeholder management skills.
- Strong technical proficiency, including Microsoft Word, Excel, PowerPoint, and MS Project.
- Detail-oriented with strong documentation and analytical skills.
- Ability to work collaboratively across departments.
- Structured and methodical approach to tasks.
- Strong time management and problem-solving abilities.
- Customer-focused approach.
Additional Skills (Preferred):
- Knowledge of 21 CFR Part 11 requirements and data integrity guidelines.
- Knowledge in Allen Bradley PLC software, FactoryTalk View software, and coordinate engineers on testing.
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