CSV Engineer

Position: CSV Engineer
Location: Raritan NJ Hybrid (2 days a week)
Client: HCL

VISA: NO H1B OPT CPT Relocation will work

Keywords: CSV Computer System Validation SAP ECC/S4 HANA validation Solman/ChaRM Change management

Description:
We are seeking a seasoned CSV Engineer with extensive experience in SAP ECC/S4 HANA system validation and Solman/ChaRM change control processes. The candidate should have a strong understanding of regulations such as 21 CFR Part 11 and Annex 11 as well as quality riskmanagement concepts (ICH Q9) and Good Manufacturing Practices principles.

Responsibilities include:

• 7 years of CSV experience with exposure in SAP ECC/S4 HANA system validation Solman/ChaRM change control process and proficiency in tools such as JIRA XRAY and qTEST for validation.
• Working knowledge of regulations: 21 CFR Part 11 and Annex 11.
• Understanding of quality riskmanagement concepts (ICH Q9) and adept in applying Good Manufacturing Practices principles.
• Experience in systems validation and quality frameworks and a riskbased quality approach.
• Perform quality review of relevant validation documentation pre and post execution for accuracy completeness and compliance with regulatory and client requirements.
• Experience in executing change control and document management.
• Knowledge of GAMP5 and Quality Systems.
• Experience with decommission Archiving and Data Integrity (ALOCA).
• Prior experience using tools like qtest Document Management system (EDMS) ServiceNow and JIRA.
• Experience in computer systems validation GXP regulatory knowledge with good documentation methods CSA approaches and riskbased validation.
• Test automation tools and methods authoring and/or reviewing validation deliverables such as Compliance Plan Summary Report Test Protocols Test Scripts Requirements and Trace Matrix.
• Experience working in Agile methodology and tools is required.

Qualifications:

• Bachelors degree in computer science Engineering or related field.
• 7 years of experience in CSV preferably in a regulated industry.
• Strong analytical and problemsolving skills.
• Excellent communication and interpersonal skills.
• Ability to work effectively in a hybrid work environment and collaborate with crossfunctional teams.

Join our team and be part of an exciting opportunity to contribute to the validation of critical systems in a dynamic environment!