Job Title: Director of Validation
Location: New Jersey, USA
Position Type: Full-Time, Permanent
Position Overview:
The Director of Validation will lead the Validation department and ensure compliance with all applicable regulations, guidelines, and industry standards. This role is critical in ensuring that the manufacturing processes, equipment, facilities, and cleaning validation meet stringent quality and safety standards. The Director of Validation will collaborate closely with cross-functional teams, including Quality Assurance, Engineering, Production, and Regulatory Affairs, to support the successful validation of all systems and processes.
Key Responsibilities:
- Develop, implement, and manage the site-wide validation strategy, including equipment, facilities, utilities, process, and cleaning validation.
- Lead and mentor the validation team, fostering a culture of continuous improvement and professional development.
- Ensure all validation activities comply with FDA, EMA, ICH, and other regulatory requirements.
- Author, review, and approve validation protocols, reports, and SOPs.
- Manage validation master plans, risk assessments, and deviation investigations.
- Oversee the qualification of new equipment, facilities, and systems, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Drive validation projects to ensure on-time delivery while maintaining quality and compliance.
- Collaborate with Quality Assurance, Engineering, and Production to resolve validation-related issues and implement corrective actions.
- Stay current with industry trends, technological advancements, and regulatory changes to continuously improve validation processes.
- Lead audits and inspections related to validation activities and address any findings promptly.
Qualifications:
- Bachelor’s degree in Engineering, Life Sciences, or a related field; advanced degree preferred.
- Masters Degree is a plus.
- 15 years of progressive leadership of operational validation experience in the Pharmaceutical or Biotechnology industry.
- In-depth knowledge of FDA, EMA, cGMP, and ICH guidelines related to validation.
- Proven track record of successfully managing validation projects and leading cross-functional teams.
- Experience in Facility, Equipment, and Utility, Cleaning Validation and Process Validation.
- Strong understanding of risk-based validation approaches and current industry trends.
- Excellent problem-solving skills and the ability to make sound decisions in a fast-paced environment.
- Exceptional written and verbal communication skills.
- Ability to work effectively in a team-oriented environment with diverse stakeholders.