SAP Implementation Support Specialist

QRC; Cidra (PR); On-site; USD 90,000 - 150,000; Full time

Job summary

QRC Group, LLC is seeking an experienced SAP Implementation Support Specialist to join our regulatory-focused manufacturing environment in the United States. You will act as on-site SAP SME, drive successful deployment, validation activities, training, and user readiness during go-live and hypercare.

Ideal candidates bring hands-on SAP implementation experience, solid knowledge of GxP, and proven ability to train users while maintaining compliance with FDA and ISO 13485 requirements.

Qualifications

• 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 FDA/ISO compliance requirements and CSV/documentation.
• Proven experience delivering end-user training in regulated environments.
• Fluent in English; Spanish strongly preferred.
• Onsite availability during go-live and hypercare periods.

Responsibilities

• Provide on-site SAP implementation and validation support.
• Support IQ/OQ/PQ and CSV requirements.
• Assist with UAT and defect resolution.
• Train end users and ensure user readiness.
• Ensure SAP processes align with FDA/ISO requirements.
• Create training materials, WIs, SOPs, and job aids.
• Provide end-user support during go-live and hypercare.
• Coordinate with IT and external SAP partners.

Skills

GxP knowledge

End-user training

Regulatory compliance

Communication

English fluency

Spanish preferred

Education

Bachelor’s degree in Engineering, Information Systems, Life Sciences, or related field

Tools

SAP MM

SAP PP

SAP QM

SAP WM

SAP SD

SAP FI/CO

Job description

Company Description

QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

Job Description

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.

Key Responsibilities

• SAP Implementation & Validation Support
• 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
• Training & User Readiness
• Develop and deliver training tailored to medical device operations (production, quality, warehouse)
• Create compliant documentation: Work Instructions (WIs), SOPs Job aids and training materialsm Coach end users on SAP transactions and best practices
• End-User Support (Hypercare)
• 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
• Regulatory & Quality Compliance
• 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
• Process Alignment & Continuous Improvement
• Identify gaps between business processes and SAP system functionality
• Recommend process improvements aligned with medical device compliance standards
• Support post-go‑live optimization efforts

Required Qualifications

• 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)

Preferred Qualifications

• 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)

Additional Information

All your information will be kept confidential according to EEO guidelines.