Validation & Engineering Group, Inc. · 3 weeks ago
MV01-080725 Sr Validation Specialist (IN)
Indianapolis, IN
Full-time
Onsite
Senior Level
5+ years expValidation & Engineering Group, Inc. is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries. They are seeking a Senior Validation Engineer to support device assembly and automation projects, ensuring compliance with regulatory and quality standards.
BiotechnologyConsultingProfessional ServicesQuality Assurance
Responsibilities
Lead or support CQV activities for equipment, utilities, and processes in accordance with cGMP and client procedures (including IQ/OQ/PQ)
Oversee design and process FMEA development and execution
Support assembly, packaging, and automation equipment qualification related to autoinjector devices
Participate in vendor reviews, FATs/SATs, and tech transfers (including international travel)
Collaborate with cross-functional teams including engineering, quality, automation, and project management
Ensure compliance with applicable regulatory and quality standards (FDA, EMA, ISO 13485, 21 CFR Part 4)
Review and approve technical documentation such as validation protocols, reports, and risk assessments
Interface with stakeholders to support project planning, scheduling, and execution
Qualification
Required
Bachelor's degree in Engineering, Life Sciences, or related field
5+ years of experience in CQV, validation, or technical operations within regulated environments
Strong knowledge of cGMPs, validation lifecycle, and regulatory expectations
Proven experience with combination products, preferably autoinjector platforms
Hands-on experience with automated device assembly equipment, vision systems, and packaging machinery
Experience with DFMEA/PFMEA methodologies
Willingness to travel internationally for vendor engagements
Excellent written and verbal communication skills
Company
Validation & Engineering Group, Inc.
Validation & Engineering Group, Proudly serving our clients since 1997.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
unknown2025-08-06Acquired
Leadership Team
Luis Puig
Partner
Recent News
News is my Business
2025-08-20
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