Expansion Validation Lead

Piramal Pharma Limited; Lexington (VA); On-site; USD 80,000 - 110,000; Full time

Job summary

Piramal Pharma Solutions, Lexington, VA, is seeking an Expansion Validation Specialist to execute validation and qualification protocols for manufacturing, packaging, lab, and utility systems in accordance with cGMP and GEP.

Reporting to the Validation Supervisor, you will coordinate with Operations, Technical Services, Facility Engineering, Microbiology, and QA, design and manage studies, develop URS, DQ, CX, and RA documents, and lead investigations into validation discrepancies to ensure

Qualifications

• Bachelor’s Degree in the 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 general compliance expectations.
• Technical writing skills and regulatory documentation experience.

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 QA for project execution.
• Lead qualification activities and timelines for equipment purchased for manufacturing.
• Represent validation at project team meetings and provide expert advice.
• Independently design, plan and manage own studies.
• Develop URS, DQ, CX, RA documents for new equipment.
• Maintain up-to-date knowledge on regulatory expectations and validation processes.

Skills

Excellent communication skills

Detail oriented

Technical writing skills

Root cause analysis

Risk assessment

Investigative techniques

Microsoft Office proficiency

cGMP knowledge

Education

Bachelor's Degree in physical or biological sciences or engineering

Tools

EDMS

Trackwise

SAP

Job description

Piramal Pharma Solutions, Lexington, VA, is seeking an Expansion Validation Specialist to execute validation and qualification protocols for manufacturing, packaging, lab, and utility systems in accordance with cGMP and GEP.

Reporting to the Validation Supervisor, you will coordinate with Operations, Technical Services, Facility Engineering, Microbiology, and QA, design and manage studies, develop URS, DQ, CX, and RA documents, and lead investigations into validation discrepancies to ensure