Engages in the day-to-day activities of the Validation function, ensuring the successful management of related activities and large projects
Job Summary
Engages in the day-to-day activities of the Validation function, ensuring the successful management of related activities and large projects.
Develop and approve cGMP documents including, but not limited to: Equipment and instrument Qualification, Commissioning, Master Validation Plans, SOP’s, Comparability reports, Aseptic Process simulation protocols and reports; process validation (PPQ), and cleaning/sterilization validation.
The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
Matching Summary
Engages in the day-to-day activities of the Validation function, ensuring the successful management of related activities and large projects.
Salary
Base: $109,900.00 - $149,900.00 annually; Bonus/Equity: Eligible for annual bonus plan and equity awards; Benefits: Comprehensive benefits package
Skills & Requirements
Must-have
cGMP compliance
validation documentation review
risk assessment knowledge
biotech sterile manufacturing
aseptic processing knowledge
validation project management
Nice-to-have
collaborative and passionate
customer focused
hands-on approach
self-motivated proactive initiative
computerized system validation
Key Requirements
BS or higher in engineering and/or related discipline OR minimum 9 years relevant experience
Minimum 5 years biopharmaceutical manufacturing, engineering, and/or validation
Minimum 5 years validation (Bachelors) or 4 years (Masters)
Must be able to work in manufacturing suites requiring gowning