Job for Senior Validation Specialist at Piramal Enterprises
Piramal Enterprises Ltd. provides a world class integrated drug discovery services platform from our state-of-the-art research Centre in India. PDS'sa delivery model has a proven track record of providing a step change in the effectiveness of drug discovery for a range of global pharmaceuticals and biotechnology companies operating at the forefront of drug discovery. PDS understands that early and intensive evaluation of the molecules based on thorough communications and rapid decision-making will lead to a high throughput of successful drug-like compounds.
Post : Sr. Validation Specialist
The Senior Validation Specialist is responsible for developing, executing, and managing Validation projects, including protocols, procedures, and training, within Piramal Pharma Solutions – Lexington. The primary purpose of the position is to provide technical and cGMP compliance support and expertise to activities performed under the validation lifecycle of the facility and its related systems, equipment, and processes. The position may specialize as a Subject Matter Expert representative in one (1) or more areas.
- Write, schedule, plan, manage, and execute validation and qualification protocols of manufacturing, packaging, laboratory, utility systems, computer software, product-specific process, and other equipment in accordance with global current Good Manufacturing Practices (cGMPs), Good Engineering Practices (GEP), and change control.
- Interact and collaborate with PPS client representatives and regulatory agencies.
- Peer review executed qualification protocols and drafted documents by other Validation staff. May be delegated as an approver based upon training and experience level, as determined by Validation management.
- Interact and coordinate technical activities with equipment and system suppliers.
- Coordinate and interface with operational, development, and quality departments to assure successful project execution.
- Represent the Validation department at project team meetings and provide expert validation advice.
- Perform routine duties as required in order to ensure the timely generation of accurate data and information.
- Maintain and develop technically-current knowledge applicable to existing and future validation processes and maintain up-to-date knowledge on regulatory expectations.
- Lead investigations related to validation event reports (discrepancies, deviations, etc.) and assure thoroughness of investigation, documentation and closure. Develop 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 and/or other departments, as appropriate.
- Assist in training program development related to validation activities and concepts for both Validation personnel and other site departments.
Candidate Profile :
- Bachelor’s degree with concentration in engineering, science, or quality required.
- Minimum of five (5) years’ experience working in a cGMP environment, with a minimum of three (3) years of validation experience.
- Must have excellent technical writing skills and problem solving ability.
- Sound knowledge, understanding, and application experience of quality management systems, including investigations, CAPAs, change management, validation lifecycle requirements, etc.
- Self-directed and able to manage priorities against assigned timelines.
- Attention to detail is required. Peer review experience is preferred.
- Validation experience with manufacturing facilities/areas (e.g. multi-product facility, warehouse, cold rooms, autoclaves, depyrogenation ovens).
- Proficiency with Microsoft Office suite (primarily Word and Excel) required.
Qualification: B.Sc, B.Pharm
Experience: 3-5 Years
Location: United States-Kentucky-Lexington
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