EXPANSION Validation Specialist
About The Position
The Validation Specialist works in the Validation department of Piramal Pharma Solutions in Lexington. Reporting to the Validation Supervisor, this role executes validation and qualification protocols for manufacturing, packaging, laboratory, utility systems, and other equipment in accordance with current Good Manufacturing Practices (cGMPs), Good Engineering Practices (GEP), and change control requirements. The role plans, schedules, manages, and executes validation activities; coordinates with internal groups and third parties; leads equipment qualification activities; and provides validation expertise to project teams. It also includes developing and maintaining validation documentation, investigating discrepancies, conducting periodic reviews, implementing corrective and preventive actions, and authoring Validation department procedures.
Requirements
- At least 2 years of QA and/or Regulatory experience in a cGMP/FDA-regulated environment.
- Thorough knowledge of cGMP regulations, guidance, and general compliance expectations.
- Technical writing skills.
- In-depth understanding of investigative techniques, including root cause analysis, risk assessment, impact evaluation, and technical report writing.
- Working knowledge of cGMP data management systems such as EDMS, Trackwise, and/or SAP.
- Thorough understanding of the Common Technical Document, particularly Chemistry and Manufacturing Controls (CMC) format, content, and US and EU filing requirements.
- High proficiency operating Microsoft Office applications.
- Excellent verbal and written communication skills.
- Detail-oriented and organized.
Nice To Haves
- Bachelor’s degree in physical or biological sciences or engineering preferred.
- Experience in sterile manufacturing of injectables strongly preferred.
Responsibilities
- Write, schedule, plan, manage, and execute validation and qualification protocols.
- Serve as a technical interface between the company and third parties for discussions about on-site validation activities.
- Coordinate with Operations, Technical Services, Facility Engineering, Microbiology, and Quality Assurance to support successful project execution.
- Lead qualification activities and timelines for equipment purchased for manufacturing purposes.
- Coordinate order timelines and equipment requirements with the Technical Services group.
- Represent Validation at project team meetings and provide expert validation advice.
- Independently design, plan, and manage studies.
- Manage development of user requirement specifications (URS), design qualifications (DQ), commissioning (CX), and risk assessments (RA) for new equipment.
- Maintain knowledge of current and future validation processes and regulatory expectations.
- Lead investigations of validation discrepancies and ensure thorough investigation, documentation, and closure.
- Implement preventive and corrective actions as necessary.
- Conduct periodic validation reviews of equipment, facilities, utilities, and sterilization cycles.
- Author assigned Standard Operating Procedures (SOPs) for the Validation department.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
