Validation Engineer

Validation Engineer ROCGJP00040856

• Hourly pay: $35-$40/hr
• Worksite: Leading biotechnology company (Tucson, AZ 85755 - Onsite)
• W2 Employment, Group Medical, Dental, Vision, Life, Retirement Savings Program, PSL
• 40 hours/week, 12 Month Assignment

A leading biotechnology company is seeking a Validation Engineer to support equipment qualification activities within a regulated manufacturing environment. This onsite role focuses on ensuring equipment and systems meet regulatory and internal quality standards through the execution of qualification protocols, risk assessments, and cross-functional collaboration. The ideal candidate will have experience in medical device, pharmaceutical, or biotechnology environments and a strong understanding of equipment validation processes and cGMP requirements.

Validation Engineer Responsibilities:

• Develop, prepare, execute, and document IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) protocols and reports for equipment and systems, ensuring compliance with regulatory and internal requirements.
• Conduct risk assessments and support the development of qualification strategies for new and existing equipment, while analyzing qualification data for accuracy, completeness, and compliance.
• Collaborate with Process Engineering, Automation Maintenance Support, Design Transfer Operations, Manufacturing, Quality, Facilities, and Safety, Health and Environment (SHE) teams to successfully execute qualification activities and achieve project milestones.
• Support process optimization and continuous improvement initiatives, provide training and guidance on qualification procedures, and ensure adherence to FDA, ISO, cGMP, and other applicable regulatory standards.
• Maintain equipment qualification documentation to ensure traceability, audit readiness, and accessibility for inspections, while performing additional validation-related duties as assigned.

Validation Engineer Qualifications:

• 1-3 years of experience in a regulated manufacturing environment, preferably within the medical device, pharmaceutical, or biotechnology industry.
• Bachelor's degree in Engineering or a Life Science discipline.
• Demonstrated experience assisting with or supporting equipment qualification activities, including the development and execution of IQ, OQ, and PQ protocols.
• Knowledge of cGMP requirements, FDA regulations, ISO standards, and other applicable regulatory guidelines.
• Strong technical writing, analytical, and problem-solving skills with the ability to interpret qualification data and prepare compliant documentation.
• Ability to effectively collaborate with cross-functional teams and communicate qualification requirements to various stakeholders.
• Experience supporting process improvement initiatives and maintaining qualification documentation for audits and inspections.
• Experience in an FDA-regulated manufacturing environment is preferred.

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