Validation Supervisor

Job Description

This position is responsible for equipment, critical utilities and facilities validation activities (i.e. included but not limited to manufacturing and packaging equipment, critical utilities including WFI, compressed gases, clean steam, etc.), that supports commercial and new R&D drug product development activities.

This highly technical and highly specialized position is responsible for generating, reviewing, and approving qualification protocols, deviations and reports; as well as scheduling manpower activities, providing internal and external customer feedback, ensuring on-time delivery of milestone activities, project staffing, and overall supervision of direct reports.

This position will also interact frequently with regulatory/compliance personnel internally. It will ensure compliance with all FDA and international regulations regarding validation activities. The employee in this role must be able to represent the company with customers and senior management.

Responsibilities:

• Provide technical expertise and understanding on the qualification, requalification and requalification approach surrounding manufacturing and packaging equipment, critical utilities and facilities.
• The individual will be a Subject Matter Expert (SME) expected to oversee the overall qualification activities related to the support activities or prerequisites to Process Performance Qualifications (PPQs, otherwise known as Process Validation).
• Support development of statistical sampling plans, assess and approve quality attribute requirements, as well as performing statistical analysis and evaluation of data to draw technical conclusions and make decisions.
• Schedule Equipment qualification activities and manage validation resources to support protocol executions.
• Plan and execute machinability protocols and review Master Batch Records where appropriate. Ensure batch records workflow is implemented to support manufacturing schedule and timelines. Ensure content of batch records meet the validated state of the process.
• Implementation of applicable regulatory requirements and guidance ensuring compliance with FDA, ISO, EMA and any other applicable domestic and international regulations.
• Schedule, plan, manage, and deploy resources to support validation activities and efforts, as needed, to ensure timelines are met.
• Effectively communicate expectations and objectives to the Validation team, motivate team members, and build teamwork environment. Effectively communicate team activities, progress, priorities, to the Director of Validations.
• Provide technical assistance for investigations into process/product issues in support of the validation deviations and review of design requirements for products and or equipment.
• Interface with customers on transfer discussions, timelines, project deliverables, etc.
• Effectively manage personal activities and manage the timeliness of the team as well as participate and/or lead/manage project related team activities. The candidate must be able to report project status and team performance capability to cross functional team members and site leadership.
• Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Qualifications:

• Bachelor of Science degree required. Advanced education is preferred
• Minimum Five (5) years’ relevant experience performing validation activities within an aseptic pharmaceutical environment is required.
• Familiarity with current industry practices and guidelines including those required / outlined by the FDA, ISO, EU and ICH.
• Certifications from institutions like ASQ, PMP, ISPE, PDA is a plus.