Job Title: Validation Manager
Supervisor: Director of Engineering
Summary of Primary Responsibilities:
This position is responsible for leading the Bedford Site’s Validation program for new and existing cGXP systems including process equipment, utilities, and information systems 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 system. The incumbent will manage master service agreements with multiple external validation service partners and also manage contract staff and project resources.
- Manages the site validation program ensuring timely execution of all re-validation requirements thru accurate requirements definition and resource planning.
- Authors, executes, and summarizes commissioning and qualification protocols for GXP systems including equipment/test instruments, utilities, processes, and IT systems.
- Coordinates the investigation, impact assessment and resolution for all validation and re-validation non-conformances.
- System owner of the site’s validation program; defines and revises procedures to ensure compliance to cGMP, GLP, FDA and worldwide regulations.
- Establishes key performance indicators in alignment with company and operational 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.
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. The position exercises broad judgment within generally defined practices and policies and exercises analytical decision-making abilities.
No direct reports, however, must be able to participate in multi-disciplined project teams and manage vendors, contractors and consultants as required.
Experience, Knowledge, and Skills Required:
- Bachelor’s degree in engineering or life sciences and 7-10 years of validation experience in pharmaceuticals or medical devices OR Master’s degree and 5-7 years.
- 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:
- 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
- Working knowledge of statistical concepts and tools