SAP Implementation Support Specialist

QRC Group, LLC•Cayey, PR

2d•Onsite

About The Position

We are seeking a SAP Implementation Support Specialist to support the deployment of SAP within a regulated medical device manufacturing environment. This individual will serve as the on-site SAP subject matter expert (SME), ensuring successful system implementation, user readiness, and compliance with industry regulations (e.g., FDA, ISO 13485). The ideal candidate has hands-on SAP implementation experience, strong knowledge of GxP environments, and proven ability to train users and support change adoption during critical go-live phases.

Requirements

Bachelor’s degree in Engineering, Information Systems, Life Sciences, or related field
3–6 years of SAP experience, including at least one full implementation
Experience in medical device, pharmaceutical, or regulated manufacturing environment
Strong knowledge of at least one SAP module (MM, PP, QM, WM, SD, or FI/CO)
Experience supporting Computer System Validation (CSV) and documentation
Proven experience delivering end-user training in a regulated environment
Working knowledge of FDA and ISO compliance requirements
Strong troubleshooting, communication, and interpersonal skills
Fluent in English (Spanish strongly preferred)
Onsite administrative shift (availability to work extended hours during go-live and hypercare period)

Nice To Haves

SAP S/4HANA experience
SAP certification (any module)
Experience with quality management processes (CAPA, NCR, traceability, batch/lot control)
Familiarity with electronic records and audit trails (21 CFR Part 11)

Responsibilities

Provide on-site SAP support during implementation, testing, and go-live
Support validation activities (IQ/OQ/PQ) in alignment with CSV (Computer System Validation) requirements
Assist with User Acceptance Testing (UAT) and defect resolution
Ensure SAP processes align with regulatory and quality requirements
Develop and deliver training tailored to medical device operations (production, quality, warehouse)
Create compliant documentation: Work Instructions (WIs), SOPs Job aids and training materials
Coach end users on SAP transactions and best practices
Act as first-line SAP support during go-live and stabilization phase
Troubleshoot issues related to transactions, master data, and workflows
Escalate technical issues and coordinate with IT and external SAP partners
Ensure SAP usage complies with: FDA 21 CFR Part 820 / Part 11, ISO 13485, Data integrity and audit trail requirements
Support audit readiness and documentation integrity
Identify gaps between business processes and SAP system functionality
Recommend process improvements aligned with medical device compliance standards
Support post-go-live optimization efforts