Onsite Pharma CSV Validation Engineer

Stark Pharma; Indianapolis (IN); On-site; USD 80,000 - 100,000; Full time

Job summary

Stark Pharma is looking for a Validation Engineer in Indianapolis to support validation activities and ensure compliance with regulatory standards. The role involves leading document migration, performing equipment qualifications, and maintaining accurate documentation in a GMP-regulated environment. Candidates should have a Bachelor's degree and at least 6 years of experience in Computer Systems Validation (CSV) and pharmaceutical manufacturing. The position is 100% onsite.

Qualifications

• 6+ years of experience in Computer Systems Validation (CSV).
• 4+ years of experience in pharmaceutical manufacturing environment.
• Hands-on experience with equipment qualification and validation.

Responsibilities

• Lead migration of legacy validation documents into the Kneat digital platform.
• Perform equipment qualification for lab instruments.
• Execute temperature mapping studies using Ellab systems or similar equipment.
• Support Computer Systems Validation (CSV) activities.
• Assist Process Engineering teams to ensure project timelines are met.
• Ensure validation activities comply with GMP and regulatory requirements.
• Maintain clear and accurate documentation.

Skills

Computer Systems Validation (CSV)

Equipment qualification

GMP regulatory compliance

Documentation migration

Education

Bachelor's degree in Engineering, Science, or related field

Job description

Stark Pharma is looking for a Validation Engineer in Indianapolis to support validation activities and ensure compliance with regulatory standards. The role involves leading document migration, performing equipment qualifications, and maintaining accurate documentation in a GMP-regulated environment. Candidates should have a Bachelor's degree and at least 6 years of experience in Computer Systems Validation (CSV) and pharmaceutical manufacturing. The position is 100% onsite.