IT CSV Engineer, Senior Validation Engineer
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Job Description
IT CSV Engineer responsible for authoring validation scripts and ensuring compliance for Snowflake Data Lake platforms in life sciences. Collaborating with cross-functional teams to maintain regulatory standards.
Responsibilities:
- Author, review, and execute validation test scripts (IQ/OQ/PQ) for GxP computerized systems
- Perform validation of Data Lake platforms and associated system interfaces, including data ingestion, transformation, and reporting layers
- Collaborate with cross-functional teams (IT, QA, Business, Data Engineering) to define validation scope, risk assessments, and acceptance criteria
- Ensure compliance with GxP, 21 CFR Part 11, and data integrity requirements throughout the system lifecycle
- Support deviation investigations, CAPAs, and change control activities related to validated systems
- Maintain validation documentation including Validation Plans, Risk Assessments, Traceability Matrices, and Summary Reports
Requirements:
- Bachelor’s degree in Computer Science, Engineering, Life Sciences, or related discipline
- 5+ years of Computer System Validation (CSV) experience in pharmaceutical or life sciences environments
- Strong experience with test script authoring and execution for GxP systems
- Experience validating Snowflake Data Lake environments and system interfaces
- Familiarity with AI/advanced data platforms is a plus
- Experience with validation management tools such as ValGenesis is a plus
- Strong understanding of GxP, 21 CFR Part 11, and data integrity principles
- Ability to work independently and manage multiple validation activities with minimal oversight
Benefits:
- High growth potential and fast-paced organization with a people-focused culture
- Competitive pay plus performance-based incentive programs
- Company-paid Life, Short-Term, and Long-Term Disability Insurance.
- Medical, Dental & Vision insurances
- FSA, DCARE, Commuter Benefits
- Supplemental Life, Hospital, Critical Illness and Legal Insurance
- Health Savings Account
- 401(k) Retirement Plan (Employer Matching benefit)
- Paid Time Off (Rollover Option) and Holidays
- As Needed Sick Time
- Tuition Reimbursement
- Team Social Activities (We have fun!)
- Employee Recognition
- Employee Referral Program
- Paid Parental Leave and Bereavement
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