SAP Go-Live & Training Specialist - Regulated Manufacturing

QRC Group; Cidra (PR); On-site; USD 85,000 - 120,000; Full time

Job summary

QRC Group in Puerto Rico seeks an SAP Implementation Support Specialist to lead on-site SAP deployment in a regulated medical device environment. You will ensure successful system implementation, user readiness, and compliance with FDA and ISO requirements.

The role requires hands-on SAP implementation, experience in GxP environments, and the ability to train users and support change during go-live and hypercare, with collaboration across IT and quality teams.

Qualifications

• Bachelor's degree in a relevant field is required.
• 3–6 years of SAP experience, including at least one full implementation.
• Experience in medical device, pharmaceutical, or regulated manufacturing environment.
• Fluent in English; Spanish strongly preferred.

Responsibilities

• Provide on-site SAP support during implementation, testing, and go-live.
• Assist with validation activities (IQ/OQ/PQ) in CSV (Computer System Validation) requirements.
• Develop and deliver training tailored to medical device operations (production, quality, warehouse).
• Ensure SAP usage complies with FDA 21 CFR Part 820 / Part 11 and ISO 13485.
• Identify gaps between business processes and SAP functionality and suggest improvements.

Skills

SAP implementation

GxP environments

User training

Stakeholder collaboration

Regulatory compliance

Education

Bachelor’s degree in Engineering, Information Systems, Life Sciences, or related field

Tools

SAP MM

SAP PP

SAP QM

CSV validation

Job description

QRC Group in Puerto Rico seeks an SAP Implementation Support Specialist to lead on-site SAP deployment in a regulated medical device environment. You will ensure successful system implementation, user readiness, and compliance with FDA and ISO requirements.

The role requires hands-on SAP implementation, experience in GxP environments, and the ability to train users and support change during go-live and hypercare, with collaboration across IT and quality teams.