Biotechnology, Life Sciences
• 4-7 years of experience in the validation of laboratory instruments including those with computerized systems attached in a biotechnology or pharmaceutical cGMP manufacturing environment
• Hands on experience operating/validating various laboratory instrument systems (e.g. AA, FT-IR, IC, ICP-MS, TOC, UV_Vis).
• Demonstrated expertise in identifying as well as formulating procedural controls to compensate for shortcomings in the system’s data integrity and FDA 21 CFR Part 11 controls.
• 3-5 years of experience in performing periodic review of laboratory instruments including those with computerized systems.
• Demonstrated understanding of global regulations on data integrity, FDA 21 CFR Part 11 and validation/qualification requirements.
• Excellent attention to detail and working knowledge of FDA Regulations/Guidance, and Good Manufacturing Practices
• Bachelor’s degree in a science or engineering related discipline with knowledge of quality operations laboratory processes.
• Bachelors in Life Sciences or Computer System
• At least 4 years experience validating equipment
• At least 2 years experience validating laboratory instruments with computer systems
• Experience in a sterile or pharmaceutical environment is required but will consider other FDA -- cGMP experience and medical device or combination product production
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