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Job Description
Validation Engineer Avispa Technology•4.8 Tucson, AZ Job Details Temporary | Full-time | Contract $35•$40 an hour 20 hours ago Benefits Dental insurance Vision insurance Qualifications Technical documentation ISO standards Regulatory compliance Technical writing within manufacturing Engineering process optimization GMP Manufacturing facility Production validation processes Continuous improvement Manufacturing Cross-functional communication Full Job Description 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. (H)
