Director, Validation

The Director Validation will lead and oversee the validation activities for our manufacturing processes, equipment, and systems at their respective facility. This role is critical to ensuring compliance with regulatory requirements and maintaining the highest standards of quality and safety in our products.

Requirements

• Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related field
• Minimum 10+ years of experience in validation within the biotechnology or pharmaceutical industry
• Excellent knowledge of regulatory requirements, industry standards (FDA, EMA, GMP, USP, ICH) and guidance (ISPE) for multiple validation disciplines
• Proven leadership experience with the ability to manage and develop a team
• Excellent project management skills, with the ability to handle multiple projects simultaneously
• Ability to work collaboratively in a fast-paced, dynamic environment
• Experience in inspection/audit presentation and response
• Strong analytical and problem-solving skills
• Excellent communication and interpersonal skills
• Detail-oriented with a commitment to quality and compliance

Benefits

• Medical, dental, and vision insurance
• 401k match
• Flexible time off
• Paid holidays including year-end shutdown