CSV/CSA Compliance Specialist

Infosys is seeking a highly skilled and detail-oriented CSV/CSA Compliance Specialist to support our S/4HANA conversion project within a regulated Life Sciences environment. The ideal candidate will have a strong background in Computer System Validation (CSV) and Computer Software Assurance (CSA), with a deep understanding of GxP regulations, including GMP (Good Manufacturing Practice) and GCP (Good Clinical Practice). This role ensures that all computerized systems meet compliance standards throughout their lifecycle.

Required Qualifications:
Candidate must be located within commuting distance of Bridgewater, NJ or be willing to relocate to the area. This position may require travel to project locations.
Bachelor's degree or foreign equivalent required from an accredited institution. Will also consider three years of progressive experience in the specialty in lieu of every year of education.
At least 4 years of overall IT experience.
4+ years of experience in a regulated Life Sciences environment (pharma, biotech, med device) in roles such as CSV, CSA, SQA, or Compliance Specialist.
Strong knowledge of GxP regulations, including GMP, GCP, and GLP, as well as FDA, EMA, and ISO standards.
Hands-on experience with validation of ERP systems (preferably SAP S/4HANA) and other enterprise applications.

Preferred Skills:
Familiarity with risk-based validation approaches and CSA principles.
Knowledge of Agile or hybrid project methodologies.
Excellent documentation, communication, and organizational skills.

Along with competitive pay, as a full-time Infosys employee you are also eligible for the following benefits:-
• Medical/Dental/Vision/Life Insurance
• Long-term/Short-term Disability
• Health and Dependent Care Reimbursement Accounts
• Insurance (Accident, Critical Illness, Hospital Indemnity, Legal)
• 401(k) plan and contributions dependent on salary level
• Paid holidays plus Paid Time Off

The job entails sitting as well as working at a computer for extended periods of time. Should be able to communicate by telephone, email or face to face. Travel may be required as per the job requirements.