SAP Implementation Support Specialist
About The Position
The SAP Implementation Support Specialist supports the deployment of SAP in a regulated medical device manufacturing environment. The role serves as the on-site SAP subject matter expert, supporting implementation, system validation, user readiness, and compliance with industry regulations such as FDA requirements and ISO 13485. The specialist provides implementation, testing, go-live, and stabilization support; assists with validation and user acceptance testing; and helps resolve defects and end-user issues. The position develops and delivers training for production, quality, and warehouse users, prepares compliant work instructions, SOPs, job aids, and training materials, and coaches users on SAP transactions and best practices. It also supports regulatory and quality compliance, audit readiness, documentation integrity, process alignment, and post-go-live optimization. The role requires on-site availability and extended hours during go-live and hypercare.
Requirements
- Bachelor’s degree in Engineering, Information Systems, Life Sciences, or a related field.
- 3–6 years of SAP experience, including at least one full implementation.
- Experience in a 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.
- Availability to work an on-site administrative shift and extended hours during the go-live and hypercare period.
Nice To Haves
- Spanish language skills.
- SAP S/4HANA experience.
- SAP certification in any module.
- Experience with quality management processes such as CAPA, NCR, traceability, and batch/lot control.
- Familiarity with electronic records and audit trails under 21 CFR Part 11.
Responsibilities
- Provide on-site SAP support during implementation, testing, and go-live.
- Support IQ/OQ/PQ validation activities in alignment with Computer System Validation (CSV) requirements.
- Assist with User Acceptance Testing (UAT) and defect resolution.
- Ensure SAP processes align with regulatory and quality requirements.
- Develop and deliver training tailored to medical device operations, including production, quality, and warehouse functions.
- Create compliant work instructions, SOPs, job aids, and training materials.
- Coach end users on SAP transactions and best practices.
- Act as first-line SAP support during go-live and the stabilization phase.
- Troubleshoot issues related to transactions, master data, and workflows.
- Escalate technical issues and coordinate with IT and external SAP partners.
- Ensure SAP usage complies with FDA 21 CFR Part 820 and Part 11, ISO 13485, and data integrity and audit trail requirements.
- Support audit readiness and documentation integrity.
- Identify gaps between business processes and SAP system functionality.
- Recommend process improvements aligned with medical device compliance standards.
- Support post-go-live optimization efforts.
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What This Job Offers
Job Type
Full-time
