SAP Implementation Support Specialist

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 materials 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:

o FDA 21 CFR Part 820 / Part 11

o ISO 13485

o 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

Requirements

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)