EXPANSION Validation Specialist

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Division

Piramal Pharma Solutions Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.

This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.

Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

For more details, please visit : www.piramalpharmasolutions.com

Job Title

EXPANSION Validation Specialist Job Description

• Business: Pharma Solutions
• Department: Validation
• Location: Lexington Job Overview

Reporting to the Validation Supervisor, 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

This position reports to the 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

Qualifications:

Bachelor’s Degree in the physical or biological sciences or engineering preferred.

2+ years of QA and/or Regulatory experience in a cGMP/FDA regulated environment

Sterile manufacturing of injectables strongly preferred

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