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:

• Bachelor's degree in engineering or life sciences or equivalent experience
• 5 years of validation/engineering experience in pharmaceuticals or medical devices
• Expertise in FDA, EMA, and ICH qualification / validation requirements and creative risk-based approaches for meeting and exceeding the minimum requirements
• Demonstrated situational leadership skills and project management expertise; ability to plan complex projects and accurately assess and manage resource requirements
• Thorough understanding of key supporting quality systems including change control, deviation / non-conformance, and CAPA. Expertise in root cause analysis
• Excellent analytical and problem-solving skills coupled with strong presentation skills
• Excellent communication skills, both verbal and written

Desired Experience, Knowledge, and Skills:

• Advanced degree or post-graduate coursework desirable
• Working knowledge using Kaye Validator or equivalent thermal mapping systems
• Direct experience in commissioning and qualification of critical utility systems, critical process equipment and computer systems
• Direct experience working in an aseptic formulation and fill manufacturing environment
• Strong knowledge of industry standards for sterility assurance in an aseptic manufacturing environment
• Solid understanding of quality risk management (QRM) principles and statistical concepts
• Subject matter expert on regulations and best practices pertaining to validation including ISO 13485, GHTF Process Validation Guidance and other applicable standards used in the medical device manufacturing