Expansion Validation Lead for cGMP Equipment

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

Job summary

Piramal Pharma Solutions in Lexington is seeking a Validation Specialist to execute validation and qualification of manufacturing, packaging, laboratory, and utility systems. You will coordinate with Operations, QA, and Engineering to ensure compliance with cGMPs and GEPs.

Reporting to the Validation Supervisor, you will develop URS, DQ, CX and RA documents, conduct investigations into validation discrepancies, and lead preventive/corrective actions while maintaining up-to-date regulatory

Qualifications

• Bachelor’s degree in physical/biological sciences or engineering preferred.
• 2+ years of QA/regulatory experience in a cGMP/FDA environment.
• Sterile manufacturing of injectables strongly preferred.
• Strong technical writing skills and regulatory documentation.
• Knowledge of investigative techniques: root cause, risk assessment, impact evaluation, technical reports.

Responsibilities

• Write, schedule, plan and manage validation protocols.
• Act as technical interface with 3rd parties for on-site validation activities.
• Coordinate with Operations, Technical Services, Facility Engineering, Microbiology and QA.
• Lead qualification activities and timelines for equipment used in manufacturing.
• Develop documents: URS, DQ, CX, RA for new equipment; maintain SOPs for Validation.

Skills

QA/regulatory experience

cGMP knowledge

Technical writing

Root cause analysis

Risk assessment

Documentation / reporting

Communication skills

Attention to detail

Education

Bachelor’s degree in science or engineering

Tools

EDMS

TrackWise

SAP

Microsoft Office

Job description

Piramal Pharma Solutions in Lexington is seeking a Validation Specialist to execute validation and qualification of manufacturing, packaging, laboratory, and utility systems. You will coordinate with Operations, QA, and Engineering to ensure compliance with cGMPs and GEPs.

Reporting to the Validation Supervisor, you will develop URS, DQ, CX and RA documents, conduct investigations into validation discrepancies, and lead preventive/corrective actions while maintaining up-to-date regulatory