Validation Specialist

Job Description

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
  
  

About Us

In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth.

Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.

Equal employment opportunity

Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.

We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.

About The Team

Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers 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 such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited’s investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide.

Job Info

• Job Identification 7700
• Job Category Validation
• Posting Date 02/11/2025, 06:01 PM
• Job Schedule Full time
• Locations 1500 BULL LEA ROAD,, Lexington, KY, 40511, US