Senior Engineer, Corporate Quality Assurance - Validation

Quva • Bethlehem Township, NJ

2d • Onsite

About The Position

The Senior Engineer, Corporate Quality Assurance – Validation is an individual contributor within the Corporate Quality Assurance organization responsible for ensuring company-wide validation and qualification activities comply with cGMP (21 CFR Parts 210/211), 21 CFR Part 11, and applicable USP and ICH guidelines. This role supports validation of equipment, processes, computerized systems, and analytical methods, including instrument qualification, method validation, and method transfer, while driving risk-based, efficient validation lifecycle practices in an FDA-regulated environment.

The position requires strong expertise in analytical validation and data integrity, with a focus on compliance, quality, and continuous improvement. The role partners across Quva sites to standardize and sustain validation methodologies, ensuring consistency and regulatory alignment. Working cross-functionally with IT, Quality, Operations, Engineering, Facilities, and Pharmacy Services, the Senior Engineer ensures validation activities are scientifically sound, compliant, and effectively executed to support both projects and routine operations.

The ideal candidate has extensive experience in pharmaceutical manufacturing, deep knowledge of analytical validation, and a strong understanding of global regulatory expectations, contributing to Quva’s mission of expanding access to high-quality, affordable medications.

Your attention to detail and adherence to precise procedures will guarantee that our medications meet the highest standards of safety, efficacy, and quality, providing patients with the best possible care and outcomes. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Chemistry, or related field (advanced degree preferred)
• 5–8+ years of experience in Quality Assurance, Validation, or related roles within the pharmaceutical or biotech industry
• Working knowledge of USP and ICH regulatory requirements
• Experience reviewing and approving validation documentation
• Familiarity with GMP (Good Manufacturing Practices) environments
• Strong background in laboratory validation
• 18+ years of age
• Able to successfully complete a drug and background check
• Must be currently authorized to work in the United States on a full-time basis; Quva is not able to sponsor applicants for work visas

Nice To Haves

• Experience in Validation roles rather than execution-focused Quality Assurance roles
• Exposure to regulatory inspections (e.g., FDA audits)
• Knowledge of data integrity principles (e.g., ALCOA+)
• Experience with electronic systems used in laboratory and validation environments (e.g., LIMS)

Responsibilities

• Ensures analytical methods are validated and transferred in compliance with ICH (e.g., Q2), USP, and regulatory expectations
• Oversees and enforces data integrity controls in accordance with FDA requirements and ALCOA+ principles
• Provides QA oversight of laboratory and validation activities to ensure compliance with internal procedures and regulatory standards
• Reviews and approves validation deliverables (e.g., IQ/OQ/PQ/PV protocols, reports, risk assessments, lifecycle documents, change controls, and Part 11 assessments), ensuring activities are appropriately designed, executed, and documented
• Authors and executes validation deliverables as needed to support business priorities
• Serves as QA representative during audits and regulatory inspections related to validation and laboratory systems
• Partners cross-functionally (QC, Validation, IT, Manufacturing) to ensure validation lifecycle compliance
• Assesses validation impact within change control processes
• Supports investigations involving validation deviations or data integrity issues
• Drives continuous improvement of validation and quality systems
• Provides technical leadership and mentor junior staff and cross-functional teams

Benefits

• Set, full-time, consistent work schedule
• Comprehensive health and wellness benefits including medical, dental and vision
• 401k retirement program with company match
• 17 paid days off plus 8 paid holidays per year
• Occasional weekend and overtime opportunities with advance notice
• National, industry-leading high growth company with future career advancement opportunities
• Annual incentive bonus

What This Job Offers

• Job Type: Full-time
• Career Level: Senior