Software Validation Engineer (Manufacturing)

Come join us and grow your career with CTG! CTG has worked with this international, Fortune 500 end-client for over 15 years! Apply with CTG for this exciting opportunity!

CTG's premier client has a contract assignment for a Software Validation Engineer.

Type: Contract

Job Title: Software Validation Engineer (Manufacturing)

Location: Remote position, must be willing to work EST schedule

Pay Rate: $55.00-$60.00/hr

Work Hours: M-F 8am-5pm

Education: Bachelor's degree in a relevant field required

Description

This position uses industry best practices and quality engineering principles to create and enforce a rigorous software validation program as part of the overall product quality architecture. The role supports evolving customer and business needs across all stages of product innovation, design/development controls, and business/manufacturing/quality software system implementation.

The Software Engineer II will work closely with various functional teams, including Manufacturing, R&D, Quality, Engineering, Procurement, and Business Operations, to develop and implement a standardized, lean, and compliant approach to software verification and validation.

Responsibilities:

• Standardize and streamline validation processes to ensure compliant software delivery

• Coordinate with functional groups to understand, document, and validate software requirements

• Lead and support continuous improvement initiatives within the organization

• Serve as a Quality representative on projects of varying scale and complexity

• Act as SME, Trainer, and Coach for software IQ/OQ/PQ validation systems

• Apply best quality engineering practices to support project teams in software validation

• Conduct internal audits to ensure compliance with quality systems

• Develop and maintain technical documentation aligned with industry standards and regulations (ISO, FDA, EU, etc.)

Requirements:

• 5+ years of experience in pharmaceutical, medical device, or biotechnology industry software quality engineering and assurance

• Background in 21 CFR Part 11-compliant software validations, including inspection systems, vision systems, MES, and material handling systems

• Knowledge of industry regulations and standards (GAMP, GMPs, ISO 9001, ISO 13485, 21 CFR Part 820)

• Experience with software used for data collection, storage, analysis, project management, and operational management systems

• Proficiency in Microsoft Office applications

• Strong communication skills and ability to work across all organizational levels

• Ability to work independently, manage multiple tasks, and drive initiatives

• Strong decision-making and problem-solving abilities

• Experience in software validation within integrated systems

• Knowledge of manufacturing processes and relevant software quality assurance practices

Additional Information:

• No third-party resumes will be accepted

• Drug testing and/or other employment-related inquiries may be conducted

• CTG will consider employment-qualified applicants with criminal histories in compliance with local, state, and federal laws

• All interested individuals MUST be able to work on a W2 Tax basis (no C2C or third-party vendors)

• CTG is an Equal Employment Opportunity employer

• CTG is an E-Verify Company