Expansion Validation Lead - Onsite Lexington

Piramal Pharma Limited; Lexington (KY); On-site; USD 70,000 - 90,000; Full time

Job summary

Piramal Pharma Solutions Lexington is seeking an EXPANSION Validation Specialist to execute validation and qualification protocols across manufacturing, packaging, labs, and utilities in line with cGMP, GEP and change control requirements.

Reporting to the Validation Supervisor, you will coordinate with Operations, Technical Services, Facility Engineering, Microbiology and QA to ensure timely project delivery, author SOPs, and maintain up-to-date knowledge of regulatory expectations.

Qualifications

• Bachelor’s degree in physical or biological sciences or engineering.
• 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 compliance expectations.

Responsibilities

• Write, schedule, plan, manage and execute validation and qualification protocols.
• Act as technical interface with 3rd parties for on-site validation discussions.
• Coordinate with Operations, Technical Services, Facility Eng., Microbiology and QA for project execution.

Skills

Technical writing

Communication skills

Detail oriented

Education

Bachelor’s Degree in physical or biological sciences or engineering

Tools

EDMS

Trackwise

SAP

Job description

Piramal Pharma Solutions Lexington is seeking an EXPANSION Validation Specialist to execute validation and qualification protocols across manufacturing, packaging, labs, and utilities in line with cGMP, GEP and change control requirements.

Reporting to the Validation Supervisor, you will coordinate with Operations, Technical Services, Facility Engineering, Microbiology and QA to ensure timely project delivery, author SOPs, and maintain up-to-date knowledge of regulatory expectations.