What are the responsibilities and job description for the Validation Specialist position at Piramal Enterprises?
Business: Pharma Solution
Department: Validation
Location: Lexington
Job Overview
The Validation Specialist executes validation and qualification protocols of manufacturing, packaging, laboratory, utility systems and other equipment, in accordance with current Good Manufacturing Practices (cGMPs), Good Engineering Practices (GEP) and change control.
Reporting Structure
Directly Reports to Validation Supervisor
Key Responsibilities
- Write, schedule, plan, manage and execute validation and qualification protocols
- Act as technical interface between the company and 3rd parties for discussions surrounding the on-site validation activities
- Coordinate and interface with Operations, Technical Services, Facility Engineering, Microbiology, and Quality Assurance groups to ensure successful project execution
- Lead qualification activities and timelines for equipment purchased for manufacturing purposes
- Coordinate order timelines and equipment requirements with Technical Services group.
- Represent validation at project team meetings and provide expert validation advice.
- Independently design, plan and manage own studies.
- Manage the development of the following documents for new equipment:
- User requirement specification (URS)
- Design qualification (DQ)
- Commissioning (CX)
- Risk assessment (RA)
- Maintain and develop state of the art knowledge regarding existing and future validation processes and maintain up-to-date knowledge on regulatory expectations
- Lead investigations related to validation discrepancies and ensure thoroughness of investigation, documentation and closure.
- Implement preventive/corrective actions as necessary
- Conduct periodic validation reviews of equipment, facilities, utilities, and sterilization cycles
Author assigned Standard Operating Procedures (SOPs) for Validation department
Education Requirements
- Bachelor’s Degree in the physical or biological sciences or engineering
Experience
- 2 years of QA and/or Regulatory experience in a cGMP/FDA regulated environment
- Sterile manufacturing of injectables strongly preferred
Competencies
- Thorough knowledge of cGMP (Current Good Manufacturing Practice) regulations, guidance, and general compliance expectations.
- Technical writing skills
- In-depth understanding of investigational techniques, including but not limited to root cause analysis, risk assessment, impact evaluation, and technical report writing
- Working knowledge of cGMP data management systems (EDMS, Trackwise, and/or SAP)
- Thorough understanding of Common Technical Document (primarily Chemistry and Manufacturing Controls (CMC) format, content, and filing requirements for US and EU.
- High level of proficiency operating all Microsoft Office applications
- Excellent communication skills, both verbally and in writing
- Detail oriented and organized
