Not specified; not specified; health, pharmacy, de...
Computer system validation experience
Equipment qualification (iq/oq/fat)
21cfr part 11 compliance knowledge
The role involves defining and managing validation strategies for computer systems and equipment while ensuring compliance with regulatory requirements
Job Summary
The role involves defining and managing validation strategies for computer systems and equipment while ensuring compliance with regulatory requirements.
Candidates will lead technical investigations, provide expert guidance during audits, and manage multiple projects with varying priorities to meet organizational goals.
The company offers a comprehensive benefits package including health insurance, retirement plans with company match, and profit sharing opportunities.
Matching Summary
The role involves defining and managing validation strategies for computer systems and equipment while ensuring compliance with regulatory requirements.
Salary
Not specified; Not specified; Health, Pharmacy, Dental, Vision, STD, LTD, Retirement Plan with match, Profit Sharing
Skills & Requirements
Must-have
Computer System Validation experience
Equipment qualification (IQ/OQ/FAT)
21CFR Part 11 compliance knowledge
Process Analytical Technology (PAT) implementation
Bilingual English and Spanish proficiency
Nice-to-have
Automation and programming skills
Project management techniques
Vendor relationship management
Continuous improvement mindset
Cross-functional team leadership
Key Requirements
Bachelor's degree in Engineering or Sciences
Minimum 7 years of related experience
Thorough knowledge of pharmaceutical industry standards