SENIOR VALIDATION ENGINEER

Company: Immatics NV
Location: Houston
Posted on: November 11, 2024

Job Description:

The purpose of this position is to lead the implementation of an ERP System through functional configuration to deployment. This position will be responsible for writing and executing all validation deliverables. This position will work with internal stakeholders and external implementation partners to ensure that the system is configured to meet our company needs.

Essential Functions:

• Experience with the implementation of SAP S4 Hana for a large complex SAP configuration within the pharmaceutical/Biotech industry is preferred.
• Support functional configuration and implementation of SAP S4 Hana while working with external implementation partners.
• Create process flow maps to capture defined and undefined processes at Immatics.
• Act as Immatics representative to ensure that the needs of the end users are met by the system.
• Work with other validation teams and vendors to facilitate integration with large complex software platforms such as Laboratory Information Management System (LIMS), Manufacturing Execution System (MES), HR/Payroll, Computerized Maintenance Management System (CMMS), Quality Management System (eQMS).
• Draft validation documents including validation plans, user requirements specification (URS), risk assessments, configuration specification documents, installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) protocols, trace matrix and summary reports.
• Execute test scripts from IQ/OQ/PQ protocols using good documentation practices and provide appropriate supporting evidence.
• Create and manage project timelines and deliverables.
• Assess new software updates and perform necessary validation activities.
• Monitor and review Quality Management Systems (CAPA, Change Controls, Deviations) and Batch Record Issuance procedures to ensure and maintain compliance with corporate and regulatory agency requirements.
• Contribute to the writing, coordination, review and approval of Quality Events when needed.
• Coordinate, support, and investigate Corrective and Preventive Actions (CAPAs).
• Draft SOPs and work instructions for system operation, maintenance and cleaning.
• Assist in Change Control process from initiation, revision of documents and processes up to training and implementation.
• Assist in preparing QMS training materials and perform training as required.
• Support cross-functional groups for QMS functions and projects not limited to Computer Systems Validation, Equipment Maintenance, Manufacturing,
• Quality Control, New Hire Onboarding, external and internal audits as needed. Competencies
  • Experience working within a GxP regulated manufacturing or laboratory environment.
  • An understanding of good documentation practices and data integrity principles.
  • An understanding of 21 CFR Part 11, 21 CFR Part 210, 21 CFR Part 211, GAMP 5 and USP
  • Experience in writing and reviewing Deviations and CAPAs, investigations resulting from OOS/OOT, environmental excursions, lab investigations leading to Change Controls for QMS.
  • Ability to make sound decisions and approach problems with curiosity and open-mindedness.
  • High degree of independent working, analytical reasoning, and the ability to communicate effectively. Work Environment:
    
    This is a sedentary position (at least 50% of time) in a typical office environment. There may be frequent interruptions with moderate noise levels and frequent use of printers, copiers, scanners, computers and other office equipment. Ability to sit, talk, walk, hear and communicate verbally and in writing is required.
    
    Physical Demands:
    • Communicating Verbally - expressing or exchanging ideas by means of the spoken word to impart oral information to others to convey detailed spoken instructions or other workers accurately, loudly or quickly.
    • Hearing - the ability to hear, understand, and distinguish speech and/or other sounds one-on-one, group or conference, telephone, and other sounds.
    • Keyboarding - entering data or text into a computer or other machine by means of a keyboard. Devices include a traditional keyboard, 10 key-pad, touch screens and others.
    • Lifting - raising or lowering an object (up to 25 lbs) from one level to another (includes upward pulling). Carrying is to transport an object - usually by holding it in the hands or arms but may occur on the shoulder.
    • Near Visual Acuity - clarity of vision at approximately 20 inches or less (working with small objects, reading small print, including the use of computers).
    • Pushing - Exerting force upon an object so that the object moves away from the object.
    • Pulling - Exerting force upon an object so that the object moves toward the force.
    • Sitting - remaining in a sitting position for at least 50% of the time.
    • Standing/Walking - remain on one's feet in an upright position at a workstation. Travel Required:
      
      This is a hybrid on-site position with less than 5% travel expected.
      
      Required Education and Experience
      • Bachelor's Degree in Science, Engineering or a related major. Education in Biotechnology or a related major preferred
      • A minimum of 5-7 years of experience working in SAP implementation projects.
      • Experience with implementation projects in the pharmaceutical/biotechnology industry in preferred
      • Experience with SAP Solution Manager for Change Control Additional Eligibility Requirements:
        • NA Work Authorization/Security Clearance Requirements
          • NA
            
            Affirmative Action/EEO Statement
            
            Immatics is an equal opportunity employer. All employment decisions including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, national origin, ethnicity, marital status, age, physical or mental disability, medical conditions, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.
            
            Other Duties
            
            Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Keywords: Immatics NV, Houston , SENIOR VALIDATION ENGINEER, Engineering , Houston, Texas