EXPANSION Validation Specialist

Piramal Pharma•Lexington, KY

About The Position

The Validation Specialist works in the Validation Department at the Lexington location and reports to the Validation Supervisor. The 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. The specialist plans, manages, and performs validation activities; coordinates with internal groups and third parties; leads equipment qualification activities and timelines; and provides validation expertise to project teams. The role also oversees preparation of new-equipment documentation, maintains knowledge of validation processes and regulatory expectations, investigates validation discrepancies, implements corrective and preventive actions, performs periodic reviews, and authors Validation Department SOPs.

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 investigational 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 Common Technical Document requirements, particularly Chemistry and Manufacturing Controls (CMC) format, content, and filing requirements for the US and EU.
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 is preferred.
Experience in sterile manufacturing of injectables is strongly preferred.

Responsibilities

Write, schedule, plan, manage, and execute validation and qualification protocols.
Serve as the 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 equipment requirements and order timelines 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 new-equipment documentation, including user requirement specifications (URS), design qualification (DQ), commissioning (CX), and risk assessments (RA).
Maintain state-of-the-art knowledge of existing and future validation processes and stay current on regulatory expectations.
Lead investigations of validation discrepancies and ensure thorough investigation, documentation, and closure.
Implement preventive and corrective actions as needed.
Conduct periodic validation reviews of equipment, facilities, utilities, and sterilization cycles.
Author assigned Standard Operating Procedures for the Validation Department.