Validation Supervisor

Business: Piramal Pharma Solutions, Inc.
Department: Validation
Location: Lexington


Job Overview
The Validation Supervisor serves as the site’s subject matter expert (SME), managing the validation program and ensuring compliance with current regulations. Incumbent works cross functionally in a team based environment to find resolutions to validation issues and ensure proper qualification documentation is completed. This position also must positively interface with internal key stakeholders, clients and regulatory agencies.

Reporting Structure

Director, Technical Operations

Key Responsibilities
- Direct oversight of validation team members
- Develop process and cleaning validation protocols, master plans, project plans, studies, and procedures.
- Generate, review, approve, and execute process, facility, and cleaning validations.
- Create validation master plans in conjunction with Quality Assurance.
- Ensure routine requalification and validation activities follow the validation policy and site validation master plan, and are in line with documentation timelines.
- Review validation documents ensuring compliance with validation requirements and good documentation practices.
- Utilize your knowledge of cleaning validation process including MAC studies, swab sampling techniques, worst case soil classifications, manual and automated cleaning procedure development, sprayball studies, cleaning recipes and cycles for CIP/SIP systems, etc.
- Participate in peer technical review of process and cleaning validation documents developed by other functional groups.
- Provide coaching on process and cleaning validation topics.
- Lead groups in creation of requirements documents, risk assessments, process and cleaning validation.
- Provide technical support in resolving process and cleaning validation related deviations including executing and managing corrective actions.
- Project management including assigning resources (internal/external), tracking and metrics to leadership.
- Oversee and manage validation contract resources including work prioritization, execution, and contractor budget.
- Evaluate and analyze validation data collected during projects, verify adequacy of the data and compliance with regulatory requirements.
- Assist engineering with equipment qualifications by participating in FATs, commissioning activities, SATs, and IOPQ events.
- Represent the validation team in client audits and regulatory inspections

Experience
- Bachelor’s Degree in the physical or biological sciences or engineering
- 8+ years’ experience in pharmaceutical operations, regulated life sciences or quality assurance
- 8+ years of QA and/or Regulatory experience in a cGMP/FDA regulated environment
- Sterile manufacturing of injectables strongly preferred
- CMO or CDMO preferred
- Prior history of Supervisory experience and team leadership
- Strong working knowledge of FDA and EU GMP regulations
- Thorough knowledge of cGMP (Current Good Manufacturing Practice) regulations, guidance, and general compliance expectations
- High proficiency in technical writing and documentation
- Ability to communicate effectively and interact with multi-disciplinary
- Excellent organizational and planning skills
- Ability to make independent decisions regarding Validation related concerns or issues
- High level of proficiency operating all Microsoft Office applications