***We are seeking a proactive Validation Engineer with 1-3 years of experience in a regulated manufacturing environment (medical devices, pharma, or biotech, preferably FDA) to ensure compliance and drive operational integrity***
Validation Engineer
Experience: 1-3 years of experience in a regulated manufacturing environment (medical devices, pharma, or biotech, preferably FDA)
Focus: Equipment Qualification
Employment Type: On-site position
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.
Nesco Resource offers a comprehensive benefits package for our associates, which includes a MEC (Minimum Essential Coverage) plan that encompasses Medical, Vision, Dental, 401K, and EAP (Employee Assistance Program) services.
Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
