Validation Engineer

Tranzeal is an industry leading global Business Transformation Service Provider offering specific consulting services as well as prepackaged, industry specific solutions and services to companies around the world. Our Consulting Services are dedicated to helping our clients maximize their investments in IT and the overall effectiveness and efficiency of the business. Tranzeal s deep industry experience makes us the partner of choice for a growing number of Fortune 1000 companies, midsize enterprises and small businesses worldwide.

We are currently looking for 'Identity

Validation Engineer

\| W2 Contract' to support one of our clients with the following skills:

Role: Validation Engineer (Local candidates only)

Location: Tucson, AZ/Onsite

Contract – 12\+ months

Responsibilities

• Develops, prepares, and executes IQ, OQ, and PQ protocols and reports for equipment/systems.
• Conducts risk assessments and develops qualification strategies for new and existing equipment/systems.
• Analyzes and interprets qualification data, ensuring accuracy, completeness, and adherence to regulatory and internal requirements.
• Collaborates with cross-functional teams, including Process Engineering, Automation Maintenance Support, Design Transfer Operations, Manufacturing, Quality, Facilities, and Safety Health and Environment (SHE), to ensure seamless execution of qualification activities and successful achievement of qualification-related project milestones.
• Participates in process optimization and continuous improvement initiatives to enhance quality and efficiency.
• Ensures compliance with FDA, ISO, and other relevant regulatory guidelines, as well as adherence to internal requirements.
• Provides training and guidance to manufacturing and quality personnel on qualification processes and procedures.
• Maintains equipment/systems qualification documentation and ensures traceability and accessibility for audits and inspections.
• Other duties as assigned by management.

Qualifications

• Bachelor's Degree in Engineering or Life Science.
• Strong technical writing, analytical, and problem-solving skills.
• Knowledge of cGMP and regulatory standards.
• Demonstrated experience assisting with or supporting qualification activities within the medical device, pharmaceutical, or biotechnology industry is required.

Interested candidates can share their resumes to [email protected]