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CSV Consultant for SAP ERP Validation and Compliance Activities (Freelancer)

Job

Arcondis Group

Brookline, MA (In Person)

Full-Time

Posted 6 days ago (Updated 12 hours ago) • Actively hiring

Expires 7/16/2026

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Job Description

CSV Consultant for SAP ERP Validation and Compliance Activities (Freelancer) at Arcondis Group CSV Consultant for SAP ERP Validation and Compliance Activities (Freelancer) at Arcondis Group in Brookline Village, Massachusetts Posted in 2 days ago.
Type:
full-time
Job Description:
Key Skills:
5+ years of Computer System Validation (CSV) experience within regulated Life Sciences environments Hands-on experience with SAP ERP validation (SAP ECC and/or
SAP S/4HANA
) Strong knowledge of GxP regulations, 21 CFR Part 11, EU Annex 11, GAMP 5, and Data Integrity requirements Experience authoring and reviewing validation deliverables (URS, FS/DS, RA, IQ, OQ, PQ, RTM, Validation Summary Reports) Experience supporting change controls, deviations, CAPAs, and periodic reviews Familiarity with SAP modules such as MM, SD, PP, QM, WM/EWM, FI/CO, or related business processes Experience working with Quality, IT, Business Process Owners, and external vendors Strong documentation, communication, and stakeholder management skills Fluent English (mandatory) Additional language skills are considered an advantage
Candidate Profile:
Experience in pharmaceutical, biotechnology, or medical device industries Proven track record supporting SAP validation activities in a regulated environment Ability to work independently and provide guidance on validation strategy and compliance expectations Experience with Agile and traditional validation approaches is desirable Support ongoing SAP ERP validation and compliance activities, ensuring validated state maintenance, change management compliance, documentation updates, and regulatory readiness.
Duration:
initially for one month with possible extension for a managed service