MTVS - Meimad TV Studios ยท 3 months ago
Validation Engineering Supervisor
Janesville, WI
Full-time
Onsite
Mid, Senior Level
$100K/yr - $115K/yr
3+ years expMTVS - Meimad TV Studios is seeking a Validation Supervisor who will be responsible for developing validation strategies to ensure systems, processes, and products meet specified requirements and regulatory standards. The role involves supervising validation initiatives and ensuring compliance with quality standards and regulations, supporting Therapeutics validation activities in a commercial manufacturing facility.
InternetMedia and EntertainmentTV Production
Responsibilities
Developing and Implementing Validation Strategies:
Create and maintain validation program ensuring it aligns with a lifecycle approach and meets regulatory requirements and project goals
Manage Master Validation Plan, through the review and implementation of all necessary standard operating procedures for plant processes, equipment installation and operational qualification (IQ/OQ), performance qualification (PQ), requalification and revalidation of critical systems and utilities
Review, plan, schedule and implement new and existing validation projects including facility systems, manufacturing equipment and processes, analytical instrumentation, and cleaning processes
Recommend validation and qualification approaches, strategies, priorities and required resources during project planning and development phases to meet FDA and EMA regulatory requirements
Responsible for managing Qualification/Validation initiatives/projects and personnel ensuring adherence to timelines and deliverables
Provide status and progress reports for validation/qualification activities or projects for the Management Review Meetings
Develop a computerized systems validation approach that meets the FDA and EMA guidelines
Validation Documentation Management:
Support the drafting of URS documents for major equipment purchases and support the onboarding of equipment into the cGMP system
Develop/draft various validation templates incorporating the lifecycle strategy
Provide guidance on development and preparation of protocols for process qualification, cleaning validation, equipment commissioning and qualification (including but not limited to FAT/SAT/IOQ and PQ) as well as CSV (Computer Software Validation) documentation to ensure data integrity requirements are met
May review and analyze analytical and physical data generated from executed validation/qualification activities
Review/draft validation/qualification final reports that present, summarize and offer conclusions on the validity of the processes based on objective evidence, obtain necessary approvals
Prepare documentation and provide support for regulatory/compliance inspections
Support internal and external audits, regulatory inspections, and remediation efforts related to equipment and software validation and compliance
Review and approve periodic reviews of system(s) validation. Ensure appropriate plans are determined for gaps identified during periodic reviews
Mentor and Train Team Members on Validation Processes and Requirements:
Managing validation activities and ensuring efficient execution of validation tasks
Support training activities related to qualification and validation activities through assignments in ACE (electronic Quality Management System) and on the job training (OJT)
Risk Management:
Work with Development, Manufacturing and Quality personnel to generate risk management deliverables for new projects, processes, and equipment (Preliminary Hazard Analysis Assessments, Criticality Assessments, System Impact Assessments, Risk Management Reports, Failure Mode and Effects Analysis)
Ensure risk management is incorporated into the validation program
Responsible for keeping the qualification/validation of the facility, equipment and processes current
Reviews proposed changes for impact to system qualification and validation. Identifies and completes requalification activities to support change completion
Collaboration:
Working closely with cross-functional teams (e.g., R&D, Quality, Engineering, IT) to ensure alignment of validation activities with other project phases and deliverables
Collaborates with cross-functional teams to meet project objectives, timelines, including scheduling, qualification testing, and deviation resolution
Continuous Improvement:
Identifying opportunities for improvement in validation processes and procedures and implementing corrective actions
Qualification
Required
BS in scientific discipline or equivalent other work experience
Previous experience of 3-5 years in validation activities in pharmaceutical or medical device company is required
Experience in cGMP environments
Strong understanding of validation principles, methodologies, and regulatory requirements
Experience is implementing validation programs to meet lifecycle approach in pharmaceutical environment
Ability to write procedures and protocols and review documentation
Ability to Supervise and motivate teams, manage projects, and communicate effectively
Ability to analyze data, identify risks, and develop effective solutions
Ability to identify and resolve issues related to validation and compliance
Excellent written and verbal communication skills for interacting with cross-functional teams and stakeholders
Benefits
Comprehensive compensation package
Company
MTVS - Meimad TV Studios
Meimad TV Studios were established with a clear purpose in mind: giving the best services for production companies and independents working in the media field, and all under one roof.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase