Senior Associate, Quality Assurance Validation

The Senior Associate, Quality Assurance Validation serves as a key Quality representative supporting capital projects, commissioning, qualification, and computer system validation (CSV) activities at a monoclonal antibody (mAb) manufacturing facility. This role partners closely with engineering, validation, and cross-functional teams to ensure facilities, utilities, equipment, and systems are designed, qualified, and maintained in line with regulatory requirements. The position is central to ensuring data integrity, regulatory readiness, and cGMP compliance across the full lifecycle of capital and validation projects.

What You'll Do

Provide Quality oversight for capital projects, serving as the QA representative throughout the project lifecycle — from design through qualification and validation. Support design, engineering, commissioning, and qualification of facilities, utilities, equipment, and computerized systems used in mAb manufacturing.
Review and approve validation lifecycle documentation, including User Requirements, Design Qualifications, FAT/SAT, IQ/OQ/PQ protocols, reports, procedures, and periodic reviews. Advise engineering and quality teams on qualification and validation strategy to ensure compliance and consistency.
Support and oversee computer system validation (CSV) activities, contributing to the maintenance and continuous improvement of data integrity processes site-wide. Drive standardization and improvement of equipment and system lifecycle documentation aligned with site operational standards.
Ensure cGMP and regulatory compliance through Quality review and oversight of site documentation. Support internal audits and regulatory inspections as needed, and help foster a strong "Safety First, Quality Always" culture across all activities.

Minimum Qualifications

Education: Bachelor's degree in a science or engineering discipline.
Experience: 5+ years in quality, engineering, or validation roles within the biologics or pharmaceutical industry, including experience with equipment lifecycle management and computer system validation (CSV).
Core skills: Strong organizational and communication skills with high attention to detail; proven ability to collaborate effectively across cross-functional teams and organizational levels; proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook).

Preferred Qualifications

Experience in materials management within USDA, FDA, or EMA regulated environments.
Demonstrated success leading cross-functional teams or projects.
Experience with SAP, JMP, and Veeva Vault systems.
Working knowledge of VICH, USDA, and/or EU GMP regulations for veterinary biologics.

Additional Details

Location: Onsite.
Schedule: Day shift, with occasional weekend or evening work to support operations.
Travel: Minimal.
Employment type: Full-time, permanent, salaried.