MV01-080725 Sr Validation Specialist

6 days ago

Indianapolis, United States Validation & Engineering Group, Inc Full time

Department: Field - NB Location: Indianapolis, IN START YOUR APPLICATION Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position: Senior Validation Engineer Job Summary: Hands on CQV/validation work supporting device assembly and automation projects for a combination autoinjector product. Ideal candidates will bring a strong cGMP background and experience with automated systems, packaging, and FMEAs. Key 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. Qualifications: 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. START YOUR APPLICATION

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