Sr Manager, Validation

About the role

Manage a professional support staff and contractors responsible for process validation of all products marketed by the company and produced by the company, independent contractors, and international company subsidiaries to include the design, implementation, and documentation of validation for manufacturing equipment, utility systems, facilities, and manufacturing processes.

Responsibilities

• Negotiate specific process validation criteria and required external resources.
• Cook
• Cover
• Represent the department regarding process validation issues during FDA meetings and audits.
• Identify and resolve validation issues on a timely basis to avoid regulatory action and make recommendations to senior management.
• Perform a wide range of managerial duties pertaining to employees including hiring, on-the-job training, career development, appraising performance, promoting, disciplining and firing.
• Identify opportunities and provide the means for employees to pursue career growth.

Requirements

• Education: Bachelor's degree in a scientific, production, or engineering related discipline is highly preferred.
• Experience: 10+ years of validation experience is required, with five to eight years of progressive leadership experience preferred.
• Pharmaceutical or Biotechnical Industry experience should exceed five years.
• Minimum of two years of demonstrated experience in sterilization validation.
• Must have strong project management experience.