MVSr Validation Specialist
Listed on 2025-12-11
-
Engineering
Quality Engineering, Biomedical Engineer, Validation Engineer
Location: Indianapolis
Career Opportunities with Validation & Engineering Group
A great place to work.
Current job opportunities are posted here as they become available.
MV01-080725 Sr Validation Specialist (IN)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.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).