Sr. Validation Engineer

TechDigital Group; Wilson (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

A leading technology firm in North Carolina is seeking a Senior Validation Engineer to lead commissioning and qualification activities for automation systems. The role involves ensuring compliance with GMP regulations and managing validation documentation for new and existing systems. Candidates should possess a degree in Engineering or Life Sciences and have 7+ years of experience in validation within the pharmaceutical or biotech industries.

Qualifications

• Minimum 7+ years of experience in validation within the pharmaceutical or biotech industry.
• Strong knowledge of cGMP, FDA, ICH, and EU regulations.
• Proven experience with commissioning and qualification of automation systems.

Responsibilities

• Lead and manage C&Q lifecycle activities including URS, DQ, IQ, OQ, and PQ for automation systems.
• Collaborate with cross-functional teams to ensure validation deliverables align with project timelines.
• Develop and review validation protocols, reports, and compliance documentation.

Skills

Life science Domain

Validation Skills

Delta V & MES Validation

Excellent communication

Project coordination skills

Education

Bachelor's or Master's degree in Engineering, Life Sciences, or related field

Tools

Kneat

GVault

Job description

Top 3 must have's: Life science Domain, Validation Skills, Delta V & MES Validation

Job Summary

The Senior Validation Engineer will lead and execute commissioning and qualification (C&Q) activities for automation systems at the. This role ensures compliance with GMP regulations and internal quality standards, supporting the successful delivery of validation documentation and execution for new and existing systems.

Key Responsibilities

• Lead and manage C&Q lifecycle activities including URS, DQ, IQ, OQ, and PQ for automation and process systems.
• Collaborate with cross-functional teams including engineering, QA, manufacturing, and automation to ensure validation deliverables align with project timelines.
• Develop and review validation protocols, reports, and supporting documentation in compliance with FDA, EU standards.
• Utilize tools such as Kneat, GVault, or equivalent systems for document control and validation tracking.
• Provide technical guidance and mentorship to junior validation engineers and contractors.
• Support change control processes and deviation investigations related to validated systems.
• Participate in audits and inspections, providing subject matter expertise on validation practices and documentation.
• Ensure alignment with the overall execution and resource plan as outlined in the C&Q strategy. [Cognizant...-June-2025 | PDF]

Required Qualifications

• Bachelor's or Master's degree in Engineering, Life Sciences, or related field.
• Minimum 7+ years of experience in validation within the pharmaceutical or biotech industry.
• Strong knowledge of cGMP, FDA, ICH, and EU regulations.
• Proven experience with commissioning and qualification of automation systems.
• Proficiency in validation tools such as Kneat, GVault, or similar platforms.
• Excellent communication, documentation, and project coordination skills.

Preferred Qualifications

• Experience working on large-scale C&Q projects in a regulated environment.
• Familiarity with systems and validation practices is a plus.
• PMP or equivalent project management certification.