Senior Quality Engineer, CSV (Non-Product)

About the Role

Key Responsibilities

• Support software lifecycle processes for non-product software in accordance with internal procedures and regulatory requirements.
• Ensure systems used in support of GxP activities are validated and maintained appropriately in compliance with applicable FDA, EU and other international regulations and ISO standards.
• Support quality risk assessment activities throughout the lifecycle of computerized systems, including system level, functional, and change risk assessments.
• Execute validation strategies and planning of validation activities; oversee execution of validation activities for non-product computerized systems.
• Review and approve validation documentation including risk assessments, validation plans, protocols (IQ/OQ/PQ), traceability matrices, and validation reports.
• Collaborate with IT, vendors, and functional departments to ensure systems are validated and maintained in their validated state.
• Maintain computer system inventory and ensure validation documentation are retained per company policy.
• Participate in change control processes to assess impact of upgrades and changes on validated systems; oversee execution of change actions.
• Coordinate and execute periodic reviews of validated systems and support development of remediation plans if needed.
• Support audits and inspections by providing validation documentation and subject matter expertise.
• Provide guidance on software assurance and CSV principles to cross-functional teams.
• Support data integrity initiatives and ensure Part 11/Annex 11 compliance of electronic records and signatures.
• Perform additional duties as assigned to support business needs.

Requirements

• Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field.
• 5+ years of experience in CSV and software assurance within the medical device, pharmaceutical, or biotech industry.
• Strong understanding of 21 CFR Part 11, Part 820, ISO 13485, ISO 14971.
• Knowledge of GAMP5 guidelines and FDA guidance on risk-based software validation and computer software assurance.
• Proven experience with SDLC and CSV documentation.
• Experience with validation and compliance of on-premises and cloud-based (SaaS) applications.
• Experience with QMS software platforms such as MasterControl, Veeva, TrackWise.
• Experience with ERP platforms like SAP, QAD, and other enterprise GxP supporting applications.
• Experience with CSV and system assurance activities for manufacturing and laboratory systems.
• Detail-oriented with strong communication, technical writing, and audit readiness skills.
• Ability to manage multiple cross-functional validation projects simultaneously.

Nice to Have

• Experience with validation of manufacturing and laboratory systems.
• Familiarity with cloud-based applications and enterprise business applications supporting GxP processes.

Benefits & Perks

• Competitive salary range of $112,000 to $145,000.
• Medical, dental, and vision insurance starting on the first day.
• Health savings account employer contributions.
• Pre-tax benefits such as FSA, dependent care FSA, and commute reimbursement.
• Travel reimbursement for medical care.
• Noncontributory life insurance and short/long term disability.
• Emotional health support, legal/financial/identity theft/pet and child referral assistance.
• Paid parental leave, holidays, travel assistance, PTO.
• 401(k) with company match, Employee Stock Purchase Plan, pet insurance discounts, unlimited LinkedIn Learning classes.