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 planningAuthors, executes, and summarizes qualification and validation protocolsCoordinates the investigation, impact assessment and resolution for all validation and re-validation non-conformancesDefines and revises validation master plans (VMPs) and procedures to ensure compliance to US FDA and applicable worldwide regulationsEstablishes key performance indicators in alignment with company, operational and engineering goals; maintain and report applicable department and system metricsSupports new product and capital project teams by defining and coordinating commissioning and qualification requirementsProvides general technical advice on new equipment and modification to existing equipment to ensure validation/qualification status is maintained in a state of controlProactively 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 neededPerforms other related duties as requiredJob 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 experience5+ years of validation/engineering experience in pharmaceuticals or medical devicesExpertise in FDA, EMA, and ICH qualification / validation requirements and creative risk-based approaches for meeting and exceeding the minimum requirementsDemonstrated 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 analysisExcellent analytical and problem-solving skills coupled with strong presentation skills Excellent communication skills, both verbal and writtenDesired Experience, Knowledge, and Skills:Advanced degree or post-graduate coursework desirableWorking knowledge using Kaye Validator or equivalent thermal mapping systemsDirect experience in commissioning and qualification of critical utility systems, critical process equipment and computer systemsDirect experience working in an aseptic formulation and fill manufacturing environmentStrong knowledge of industry standards for sterility assurance in an aseptic manufacturing environmentSolid understanding of quality risk management (QRM) principles and statistical conceptsSubject 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

Created: 2024-11-10