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 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:
  

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)