Job Title: ERP/SCM Senior Validation Lead
USDM Life Sciences is a leading global consulting firm focused on life sciences, specializing in regulated business processes, with an emphasis on compliance and performance. We are seeking a Senior Validation Consultant who has experience with ERP/SCM systems (Oracle EBS/Oracle Cloud/SAP R/3).
• Participate in a multi-phase project for the preparation and execution of Computer System Validation deliverables (SDLC) of the GMP functions of SAP or Oracle
• Work with regional manufacturing sites as defined in the Computer Master Validation Plan.
• The Senior Validation Consultant will provide an advisory and hands-on role as needed. This may include:
o Advising clients on assigning proper risk and risk mitigation to cloud based ERP/SCM systems.
o Advising clients on how to meet FDA, EMA, and MHRA compliance requirements.
o Advising clients on developing tests that provide adequate compliance coverage as well as thoroughly tests business requirements (functional and non-functional).
o Writing and executing computer validation deliverables or Standard Operating Procedures as pertaining to GxP cloud-based computerized systems.
• Work with client to develop Validation Plan to ensure that, at the end of the project, the system meets FDA, EMA, and MHRA compliance requirements.
• Work with client business functions and subject matter experts to develop User Requirements, Functional and Configuration Specifications, and Functional Risk Assessment (FRA) via FMEA to establish hardware/software requirements.
• Develop test / validation scripts based on software / hardware design / configuration.
• Develop Installation/Configuration tests / qualifications scripts based on Design.
• Develop Operation tests / qualifications scripts based on functional requirements.
• Develop Performance tests / qualification scripts based on user requirements.
• Interact in a team environment, managing tasks and escalating issues as needed.
Education & Experience/Technical Competencies:
• BS Engineering, Computer Science or related Life Science
• Minimum 10 years in pharmaceutical industry, focusing on Systems Validation or IT Quality.
• Thorough understanding of the principles of GAMP, SDLC methodologies, testing best practice, and cloud based systems.
• Thorough understanding of Enterprise Resource Processing (ERP)/Supply Chain Management. (SCM) business processes (e.g. inventory management, shipping, receiving, order management, procurement, process manufacturing, PLM) as they pertain to pharmaceutical, biotech, medical device companies.
• Expertise in use and validation of computerized GxP systems including cloud based SaaS.
Key Requirements and Technology Experience and Skill sets:
• 5-7 years computer validation experience (FDA- biotech/pharma).
• Thorough understanding of CSV or IT Quality processes and documentation requirements for validation of SAP or Oracle EBS/Cloud.
• Experience validating and working with enterprise systems such as SAP or Oracle EBS/Cloud is required.
• Fluent knowledge of rules and regulations: GAMP 5, Data Integrity, 21 CFR Part 11 Compliance, 21 CFR Part 210, 211 Compliance, and EudraLex Volume 4 Annex 11.
• Fluent in Microsoft Office suite /including (Word, Excel, Power Point, Visio, Project).
• Ability to work independently.
• Strong organizational/ facilitation/communication skills.
• Strong verbal, written and presentation skills.