Validation & Engineering Group
MV01-080725 Sr Validation Specialist (IN)
Validation & Engineering Group, Indianapolis, Indiana, United States, 46217
Job Description
Job Description
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.
Job Description
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.