We are seeking a Quality Engineer to support validation activities within a regulated manufacturing environment, with strong involvement in process validation, equipment qualification, and quality systems compliance. This role requires hands-on experience in validation processes (PV and CSV), risk management, and regulatory documentation, supporting projects from requirements definition through execution. The position is on-site, full-time, and requires collaboration with cross-functional engineering and manufacturing teams.

Key Requirements:

• Bachelor’s degree in Engineering 
• 4+ years of experience in validation processes within Pharma, Biotech, or Medical Device industries
• Experience performing and/or reviewing Process Validation (PV: characterization, OQ, PQ) and Equipment Qualification (CSV: URS, FAT, IQ, OQ, PQ, TMV)
• Basic knowledge of validation strategy development, including requirements flow-down from design to manufacturing
• Experience with risk management documentation, including pFMEA
• Basic knowledge of statistics (preferably using Minitab)
• Experience supporting projects related to design requirements validation and manufacturing controls

Preferred Experience:

• Investigating manufacturing events in support of product disposition
• Identifying and analyzing manufacturing defect and reject trends
• Knowledge of Medical Device regulations (FDA, ISO, GMP, GAMP 5)
• Experience with Design Transfer activities and execution

Key Responsibilities:

• Conduct compliant validation processes for quality systems requiring formal documentation under regulatory requirements
• Develop, execute, and review validation documentation (URS, FAT, IQ, OQ, PQ, TMV, validation reports)
• Support full validation lifecycle, including risk assessments, traceability matrices, and deviation management
• Perform statistical analysis and support sampling plans for validation activities
• Investigate manufacturing issues and support product disposition decisions
• Track and analyze manufacturing trends, defects, and non-conformances
• Coordinate with cross-functional teams, vendors, and engineering groups to support validation execution
• Ensure compliance with FDA, ISO, GMP, and other applicable regulatory standards
• Support audits, regulatory inspections, and continuous improvement initiatives
• Report validation status and progress to ensure timely project completion

Benefits:

• Health insurance (Medical, Dental, Vision, Pharmacy)
• Life Insurance
• Paid time off (PTO)
• Holidays
• Professional Growth (Courses and Certifications by EQVAL Academy)
• Referral program
• Productivity incentive