Overview
IT Tester – Remote Jobs in Falls Church, VA at Creative Information Technology India
We are seeking a highly skilled Lead Engineer, Quality Validation to provide technical and quality oversight for process validation and qualification activities across internal manufacturing and Contract Manufacturing Organizations (CMOs)/Contract Testing Labs (CTLs). This role is crucial in ensuring compliance with regulatory guidelines while supporting drug product technology transfer, process qualification, and validation activities. The ideal candidate will have expertise in GMP, process validation, and risk-based qualification strategies in the biopharmaceutical or pharmaceutical industry.
Required Qualifications:
Bachelor’s degree in Science, Engineering, or a related field (advanced degree preferred).
8-12 years of experience in biopharmaceuticals, pharmaceuticals, or related industries.
Proven expertise in process validation, qualification, and technology transfer per FDA, ICH, and GMP regulations.
Hands-on experience working with CMOs and drug product manufacturing environments.
Strong knowledge of analytical method qualification/validation (FDA, USP, ICH guidelines preferred).
Familiarity with biologics, gene therapy, and aseptic processing is a plus.
Ability to solve complex validation challenges with innovative solutions.
Excellent verbal, written, and interpersonal communication skills.
Job Type: Contract
Pay: $75.00 – $80.00 per hour
Expected hours: 40 per week
Benefits:
401(k)
401(k) matching
Dental insurance
Health insurance
Life insurance
Vision insurance
Schedule:
8 hour shift
Experience:
contract manufacturing organizations (CMOs): 8 years (Required)
drug product manufacturing: 8 years (Required)
gene therapy: 2 years (Preferred)
CGMP: 8 years (Required)
Work Location: In person
Title: IT Tester – Remote
Company: Creative Information Technology India
Location: Falls Church, VA
