We are looking for a dedicated and experienced Validation Supervisor to lead validation activities at our pharmaceutical services site in León, Spain. This role plays a key part in supporting clinical and commercial operations, ensuring that equipment, systems, utilities, processes, and cleaning activities are validated and maintained in compliance with applicable regulatory requirements and internal quality standards.
Key Responsibilities:
- Supervise validation activities including process validation, equipment and utility qualification, cleaning validation, and computer system validation.
- Lead a team of validation professionals, providing guidance, workload planning, training, and development.
- Oversee the creation and execution of validation documentation including protocols, reports, and risk assessments in line with current GMP, EU Annex 15, FDA, and ICH guidelines.
- Support validation efforts for new product introductions, technology transfers, equipment installations, and facility expansions.
- Collaborate closely with Quality Assurance, Engineering, Manufacturing, IT, and Project Management teams to ensure alignment and timely delivery of validation objectives.
- Ensure data integrity compliance within all validation-related activities, particularly in computerized systems.
- Participate in regulatory inspections and client audits as the site validation SME.
- Drive continuous improvement initiatives across validation processes and procedures.
Qualifications:
- Bachelor’s degree in Engineering, Pharmacy, Chemistry, Life Sciences or a related technical discipline; Master’s degree preferred.
- Minimum 5 years of experience in validation within the pharmaceutical, biotechnology, or CDMO environment.
- At least 2 years of experience in a supervisory or technical lead capacity.
- Strong understanding of GMP regulations, EU and FDA validation guidelines, and industry standards (Annex 15, ICH Q8-Q10).
- Experience in managing validation for high-potency compounds, cold chain systems, and serialized packaging lines is highly desirable.
- Fluent in both Spanish and English (written and verbal).
- Strong organizational, communication, and leadership skills with the ability to manage multiple priorities.
Preferred Experience:
- Working knowledge of global regulatory expectations related to clinical and commercial packaging.
- Familiarity with electronic validation systems and digital documentation tools.
- Experience in a fast-paced, client-focused contract manufacturing or packaging environment.
