Validation Manager $100-120K - Sterile Pharmaceuticals Manufacturing - Manage the planning, preparation, and conduct of validation functions for an aseptic clinical trial manufacturing and commercial manufacturing facility including but not limited to Equipment/Utility/Facility Qualification, Cleaning Validation, Process Validation, Computer / Automation qualification and validation across the entire validation lifecycle. Manage performance and development of direct reports to ensure achievement of organizational and department goals and create a productive environment. Lead validation team members, assign resources to projects, and manage validation schedules to ensure activities are in compliance, on time, and within budget. Provide validation strategy for the organization, capital projects, and for client-specific projects. Provide budgetary input for validation tasks for client projects and for departmental budget. Manage direct reports including selection, hiring, training, goal / development planning, talent review, discipline, promotion and termination. Build or revise validation infrastructure (SOPs, standard practices) and ensure procedures are aligned with corporate quality policies. Review and approve validation documentation including but not limited to validation plans, protocols, and reports, and validation deviations; Responsible for updates to the Validation Master Plan. Prepare and execute validation protocols, analyze data and write reports.
Compliance activities such as: Ensure validation deviations are thoroughly and completely investigated; interact with interdepartmental contacts on deviation assessment, resolution and quality approval; participate in non-validation deviations or investigations as needed. Assist with or interact with regulatory agencies and clients and present validation documentation.
Review / assess change controls for validated systems and provide validation guidance and requirements for change controls; member of the change control team.
Bachelor’s degree in Science or Engineering discipline.10 years experience in the pharmaceutical industry in a validation role in an aseptic processing environment. Strong problem-solving and critical thinking skills with demonstrated ability to conduct technical programs and to achieve program goals. 3-5 years of supervisory experience with technical staff. Good computer skills; Excellent interpersonal skills; Excellent written and verbal communication skills to communicate with both technical and non-technical internal and client representatives. Comprehensive knowledge of controlled release technology. Ability to work closely with other workgroups in order to successfully complete projects on time and in full.
Compliance activities such as: Ensure validation deviations are thoroughly and completely investigated; interact with interdepartmental contacts on deviation assessment, resolution and quality approval; participate in non-validation deviations or investigations as needed. Assist with or interact with regulatory agencies and clients and present validation documentation.
Review / assess change controls for validated systems and provide validation guidance and requirements for change controls; member of the change control team.
Bachelor’s degree in Science or Engineering discipline.10 years experience in the pharmaceutical industry in a validation role in an aseptic processing environment. Strong problem-solving and critical thinking skills with demonstrated ability to conduct technical programs and to achieve program goals. 3-5 years of supervisory experience with technical staff. Good computer skills; Excellent interpersonal skills; Excellent written and verbal communication skills to communicate with both technical and non-technical internal and client representatives. Comprehensive knowledge of controlled release technology. Ability to work closely with other workgroups in order to successfully complete projects on time and in full.