What are the responsibilities and job description for the MV01-080725 Sr Validation Specialist (IN) position at Validation & Engineering Group, Inc.?
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:
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
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
- Senior Validation Engineer
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.
- 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.