PSC Biotech Corporation
201 - 500 employees
Founded 1996
💼 Consulting
🏥 Healthcare
🧬 Biotechnology
Consulting • Healthcare • Biotechnology
PSC Biotech Corporation is a life science consulting solutions partner that offers a wide range of engineering, technical, and consulting services focused on enhancing operational efficiency, compliance, and quality assurance within the biotech and pharmaceutical sectors. Their expertise includes areas such as auditing, regulatory affairs, commissioning, validation, and project management, helping organizations mitigate risks and streamline processes for successful outcomes in regulated environments.
SAP CSV Lead
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PSC Biotech Corporation
201 - 500 employees
Founded 1996
💼 Consulting
🏥 Healthcare
🧬 Biotechnology
Consulting • Healthcare • Biotechnology
PSC Biotech Corporation is a life science consulting solutions partner that offers a wide range of engineering, technical, and consulting services focused on enhancing operational efficiency, compliance, and quality assurance within the biotech and pharmaceutical sectors. Their expertise includes areas such as auditing, regulatory affairs, commissioning, validation, and project management, helping organizations mitigate risks and streamline processes for successful outcomes in regulated environments.
📋 Description
• Provide strategic leadership and oversight for Computer System Validation (CSV) and Computer Software Assurance (CSA) activities supporting SAP S/4HANA and related SAP platforms in regulated Life Sciences environments • Partner with Quality, IT, Business Process Owners, and project teams to ensure SAP S/4HANA solutions are implemented, validated, and maintained in compliance with GxP regulations and industry best practices • Lead and oversee CSV and CSA activities for SAP S/4HANA, SAP Cloud ALM, and related business applications • Provide validation leadership throughout SAP S/4HANA implementations, enhancements, upgrades, and ongoing operational support • Establish and execute validation strategies aligned with regulatory requirements, company procedures, and industry best practices • Guide validation lifecycle deliverables, risk assessments, testing approaches, and compliance documentation • Ensure validation activities support data integrity, system reliability, and regulatory compliance objectives
🎯 Requirements
• Bachelor's degree in Engineering, Computer Science, Information Systems, Life Sciences, or related discipline • 3–6 years of experience supporting and validating SAP S/4HANA environments • Significant experience supporting and validating SAP platforms and business-critical enterprise systems • Demonstrated experience leading validation efforts for SAP implementations, upgrades, or transformation initiatives • Experience utilizing SAP Cloud ALM within validation, testing, or application lifecycle management activities • Strong understanding of GxP regulations and computerized system compliance requirements • Experience supporting large-scale SAP transformation or digital modernization programs • Experience working with global, cross-functional project teams • Must be authorized to work in the U.S. without current or future sponsorship requirements • No C2C at this time
🏖️ Benefits
• Compensation and benefits structure that rewards you • Tools to help you grow and learn • Coaching and professional development opportunities • Travel expenses reimbursed in accordance with company policy
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