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)