Validation Specialist

Net2Source Inc
: 5+ Years
: Rocky Mount, NC, USA
Salary : Salary Not Disclosed By Employer
Openings : 1
Job Function : Healthcare
Industry : Biopharmaceuticals
Qualification : Any Graduation
Certification Required (if any) : Not Mentioned
Notice Period : Not Mentioned

Key Skills

Biotechnology, Life Sciences

Job Description

Validation Specialist

• 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

Company Info.

Net2Source Inc

Staff Augmentation, Direct Hires, RPO, Contingent Hiring, Application Development, MSP/VMS Sales, Product Development, Project Management, Infrastructure Management, IT Support Services, Call Center Services, BPO, Coshoring and VMO, recruitment, RPO, Managed Services, Direct hiring, and payroll

Similar Jobs View More

Recommended Profiles