Validation & Engineering Group, Inc.
MV01-080725 Sr Validation Specialist (IN)
Validation & Engineering Group, Inc., Indianapolis, Indiana, us, 46262
MV01-080725 Sr Validation Specialist (IN)
MV01-080725 Sr Validation Specialist (IN)
4 days ago Be among the first 25 applicants 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.
Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Strategy/Planning and Information Technology Referrals increase your chances of interviewing at Validation & Engineering Group, Inc. by 2x Get notified about new Senior Validation Specialist jobs in
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MV01-080725 Sr Validation Specialist (IN)
4 days ago Be among the first 25 applicants 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.
Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Strategy/Planning and Information Technology Referrals increase your chances of interviewing at Validation & Engineering Group, Inc. by 2x Get notified about new Senior Validation Specialist jobs in
Indianapolis, IN . Lead Senior Computerized System Validation (CSV) Consultant
Senior Manager, IT - GxP Computer Systems Validation & IT Process Lead
Indianapolis, IN $50,000.00-$240,000.00 1 month ago Validation Expert for Manufacturing Equipment Qualification
Indianapolis, IN $87,152.00-$94,600.00 22 hours ago LL02-250725 Validation Specialist for Aseptic Process/Media Fill (IN)
Indianapolis, IN $67,500.00-$101,220.00 2 weeks ago Indianapolis, IN $70,491.00-$100,000.00 5 days ago Principal Scientist, TSMS Cleaning Validation - ADN RAMP Team
Indianapolis, IN $64,500.00-$167,200.00 1 week ago Principal Scientist, TSMS Cleaning Validation - ADN RAMP Team
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr