MV01-080725 Sr Validation Specialist (IN) jobs in United States
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Validation & Engineering Group, Inc. · 5 months ago

MV01-080725 Sr Validation Specialist (IN)

positionIndianapolis, IN
timeFull-time
remoteOnsite
senioritySenior Level
date5+ years exp

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier providing solutions for various industries including Pharmaceutical and Biotechnology. They are seeking a Senior Validation Engineer to lead CQV activities for 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

CQVCGMPAutomated device assemblyCombination productsDFMEA/PFMEACommunication skills

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.

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Validation & Engineering Group, Proudly serving our clients since 1997.
dateFounded in 1997
location
Guaynabo, NA - Puerto Rico, PRI
people-size51-200 employees
web-link
http://veg-group.com/

Funding

Current Stage
Growth Stage
Total Funding
unknown
2025-08-06Acquired

Leadership Team

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Luis Puig
Partner
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Recent News

News is my Business
Pinnaql buys Validation & Engineering Group to boost life sciences reach
2025-08-20
PR Newswire
Pinnaql Acquires VEG, Broadening Manufacturing Compliance & Quality Services Platform
2025-08-06
Company data provided by crunchbase