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.