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
Support change control, configuration management, and release activities
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

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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

CSVCSAvalidation supportvalidation lifecycle documentationSDLC processestest artifacts reviewrequirements traceabilitychange controlsconfiguration managementrelease activities

Soft Skills

collaborationeffective communicationremote teamwork