Key skills
SDLCSAP
About this role
Role Overview
- Execute CSA and validation activities in accordance with SDLC procedures and quality expectations
- Assist in preparation of validation plans, functional risk assessments, and traceability matrices
- Support review of validation/testing documentation and change control artifacts
- Contribute to validation summary reporting and lifecycle compliance deliverables
- Provide support for CMDB management and validation tool usage as needed
- Collaborate with Digital Quality, System Owners, and Business stakeholders throughout execution
Requirements
- 2–5+ years in CSV/CSA or regulated system validation support
- Working knowledge of validation lifecycle documentation and SDLC processes
- Experience reviewing test artifacts, requirements traceability, and change controls
- Ability to operate effectively in a remote, globally distributed team
- Preferred exposure to SAP or enterprise platform validation
- Preferred familiarity with GxP documentation practices and ALCOA+ principles
- Preferred experience supporting validation execution within life sciences
Tech Stack
- SDLC
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