SAP Implementation Support Specialist

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 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)
  

Requirements
Bachelor’s degree in Life Sciences, Education, Engineering, Business Administration, Organizational Development, or a related field. Minimum of 5 years of experience supporting training compliance, quality systems, or learning management processes within a regulated industry. Experience working in Medical Device, Pharmaceutical, Biotechnology, or FDA-regulated manufacturing environments. Strong knowledge of training systems, qualification processes, and compliance requirements. Experience managing training records, curricula, learning management systems (LMS), and employee qualification programs. Understanding of Good Documentation Practices (GDP), Quality Management Systems (QMS), and regulatory expectations. Strong project management, organizational, and stakeholder management skills. Excellent written and verbal communication skills. Ability to analyze training compliance data and implement corrective actions when necessary. Willingness to travel within the US-East region as required. Preferred Qualifications Experience supporting large-scale remediation, inspection readiness, or compliance improvement projects. Familiarity with FDA regulations, ISO 13485, and medical device quality systems. Experience with Learning Management Systems (LMS) within regulated environments. Certification in Quality, Compliance, Training, Lean Six Sigma, or Project Management. Experience leading training governance and audit readiness initiatives. Key Competencies Training Compliance Management Quality Systems & Regulatory Compliance LMS Administration & Training Records Audit Readiness & Inspection Support Remediation Program Support Training Effectiveness & Qualification Management Continuous Improvement Stakeholder Engagement Documentation Compliance Project Leadership