CNC Validation Analyst - Warsaw, IN

Job Title: CNC Validation Analyst
Location: Warsaw, IN
Position Type: Full Time (NO C2C)
Salary: DOE
US Citizen, Green Card and GC EAD preferred.
No sponsorship available for this job, direct hire
Local candidates preferred.

Job Description:
Technical/Functional Skills:

• At least 5 - 7 years' hands-on experience in Software Validation in the Pharmaceutical and/or Medical Devices industries.
• Strong understanding of CNC software Validation
• Experience with validation of manufacturing shop floor applications
• Experience in authoring/executing Validation Master Plan, Risk Assessment/GxP assessment, VP, URS, TM, IQ, OQ, PQ protocols, Final Validation Report.
• Experience in process validation.
• Excellent Communication skills is a must
• Ensuring that process followedfully comply with regulatory requirements, company policies and procedures
• Actively maintain the Inventory of existing applications, conducting CSV determination assessment and risk assessment and mentor the team for the same.
• Manage the execution of remediation procedure for the inventoried systems
• Ability to work with teams based at onsite and offshore and achieve project objectives
• Experienced and guiding software validation team in creating quality documents adhering to GAMP5 and 21 CFR 820 requirements
• Demonstrated ability to learn new areas and apply Validation principles
• Strong Experience in GAMP4/GAMP5 based validation
• Experience in validating systems against 21 CFR Part 11