Lead Validation Specialist: cGMP Equipment & QA

Piramal Pharma Solutions Inc.; Lexington (KY); On-site; USD 65,000 - 90,000; Full time

Job summary

Piramal Pharma Solutions is seeking a Validation Specialist in Lexington to execute validation and qualification protocols across manufacturing, packaging, laboratory, and utility systems in alignment with cGMP and GEP. You will interface with 3rd parties, coordinate with Operations, QA, and Engineering, and author core validation documents.

The role requires a Bachelor’s degree in a physical/biological science or engineering with 2+ years in QA/regulatory environments and strong technical

Qualifications

• Bachelor’s Degree in 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 regulations, guidance, and general compliance expectations.
• Technical writing skills.
• In-depth understanding of investigational techniques, including root cause analysis and risk assessment.
• Working knowledge of cGMP data management systems (EDMS, Trackwise, and/or SAP).
• Strong documentation and communication abilities.

Responsibilities

• Write, schedule, plan, manage and execute validation and qualification protocols.
• Act as technical interface between the company and 3rd parties for on-site validation activities.
• Coordinate 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.
• Develop documents for new equipment: URS, DQ, CX, RA.
• Maintain up-to-date knowledge on regulatory expectations.
• Lead investigations related to validation discrepancies and ensure closure.

Skills

QA experience

Regulatory experience

cGMP knowledge

Technical writing

Communication skills

SAP knowledge

Education

Bachelor’s degree in physical or biological sciences or engineering

Tools

EDMS

Trackwise

SAP

Job description

Piramal Pharma Solutions is seeking a Validation Specialist in Lexington to execute validation and qualification protocols across manufacturing, packaging, laboratory, and utility systems in alignment with cGMP and GEP. You will interface with 3rd parties, coordinate with Operations, QA, and Engineering, and author core validation documents.

The role requires a Bachelor’s degree in a physical/biological science or engineering with 2+ years in QA/regulatory environments and strong technical