Validation Supervisor
People & HR, Operations
Tennessee, USA
Reporting to the Senior Director of Validation and Metrology, the Validation Supervisor will be responsible for providing leadership and guidance in validation-related tasks to the validation team with up to 5 direct reports. The Supervisor independently directs and performs validation tasks to meet customer needs and comply with cGMPs. The supervisor will manage validation projects and serve on validation project committees. Develop Validation Master Plans and provide guidance for best validation practices. The supervisor will also represent the Validation Department on interdisciplinary facility teams and client meetings/visits. The Supervisor will be considered a subject-matter expert in certain validation methods and practices and will represent August Bio in both agency and customer audits.
Responsibilities
- Maintain the validation team project schedule.
- Tracks the progress and success of their direct reports.
- Helps to develop goals for direct reports.
- Write Validation Master plans and all other validation protocols, including IOQ’s, PQ’s, final reports, and SOPs.
- Manage the qualification and re-qualification schedule.
- Provide reviews and oversight to validation reports and periodic reviews.
- Provide training for both internal and contract personnel.
- Proactively identifies potential obstacles to successful project completion and helps establish remediation for them.
- Develops Validation acceptance criteria.
- Provides leadership in the field and executes validations in the field.
- Provides acceptance criteria based on agency guidelines and best practices.
- Recommends validation procedural and test improvements.
- Review equipment drawings and facility P&IDs from a validation perspective.
- Manages resource support for validation projects
- Schedule and chair interdepartmental project meetings
- Participates as a validation representative on failure investigation teams.
- Represent August Bio as validation SME for agency and customer audits
Qualifications
- Excellent verbal and written communication skills
- BS in Biology, Biochemistry, Microbiology, or Chemical Engineering
- 6+ years of Validation experience in Pharmaceutical, Biological or Biotech industry
- Experience managing a team, or significant experience coaching and mentoring team members
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Prolonged periods sitting at a desk and working on a computer.
- Must be able to lift up to 50 pounds at times, and up to 30 pounds frequently.
August Bioservices is an equal opportunity employer and values diversity. All aspects of employment, including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. August Bioservices does not discriminate on the basis of any status protected under federal, state, or local law.