The role supports key site digital/software/automation transformation and validation activities to meet site goals and regulatory requirements
Job Summary
The role supports key site digital/software/automation transformation and validation activities to meet site goals and regulatory requirements.
The position offers eligibility for short-term incentive bonuses, equity-based awards, and comprehensive benefits including retirement programs and health coverage.
The company is committed to building an inclusive environment with equal employment opportunities and accommodations for applicants with disabilities.
Matching Summary
The role supports key site digital/software/automation transformation and validation activities to meet site goals and regulatory requirements.
Salary
Base: $101,643.20 - $152,464.80; Bonus/Equity: Short-term incentive bonuses and equity-based awards; Benefits: Retirement programs, paid time off, health, dental, and vision coverage
Skills & Requirements
Must-have
Computer system validation
Qualification and validation protocols
Risk assessment and change control
Data analysis for process control
Digital tools and MES systems
GxP compliance and lifecycle management
Nice-to-have
Ability to read P&IDs and electrical drawings
Experience with FDA guidance on validation
Programming for digital/software validation
Hardware and software integration knowledge
Strong moral principles and work ethics
Adaptability to changing requirements
Key Requirements
Master’s/PhD or Bachelor’s with 3+ years experience
3+ years independent qualification/validation experience
Experience in control systems qualification
Excellent analytical and technical writing skills
Ability to perform and document deviations and investigations