Validation Manager

Summary of Primary Responsibilities :

This position is responsible for managing the Bedford Site's Validation program that includes start-up, commissioning, qualification, validation and revalidation projects for facility, equipment, critical utility, automation / computer system, cleaning, sterilization, and medical device / drug product manufacturing processes according to current Good Manufacturing Practices (cGMP), ISO requirements, and ICH guidelines. Reporting to the Director of Engineering, this position works internally across the Anika organization to define, administer, and continuously improve the site's validation programs.

Responsibilities :

• Manages the site validation program ensuring timely execution of all validation / re-validation requirements through accurate requirements definition and resource planning
• Authors, executes, and summarizes qualification and validation protocols
• Coordinates the investigation, impact assessment and resolution for all validation and re-validation non-conformances
• Defines and revises validation master plans (VMPs) and procedures to ensure compliance to US FDA and applicable worldwide regulations
• Establishes key performance indicators in alignment with company, operational and engineering goals; maintain and report applicable department and system metrics
• Supports new product and capital project teams by defining and coordinating commissioning and qualification requirements
• Provides general technical advice on new equipment and modification to existing equipment to ensure validation / qualification status is maintained in a state of control
• Proactively identify, assess, and mitigate operational and organizational risks; escalate key risks and issues
• Support development of department's annual operating budgets; partner with Finance to analyze variances and implement adjustments as needed
• Performs other related duties as required

Job Complexity :

The job requires the ability to act on problems of diverse and highly technical scope, requiring critical thinking and interaction with internal and external technical professionals.

Implements strategic policies and adheres to budgets, schedules, work plans, and performance requirements. The position exercises broad judgment within generally defined practices and policies and exercises analytical decision-making abilities.

Supervisory Responsibilities :

Manage validation engineering direct reports and vendors, contractors and consultants as required.

Experience, Knowledge, and Skills Required :

Desired Experience, Knowledge, and Skills :