Division Quality Engineer I

Role Purpose

Key Responsibilities

• Support the standardization of computer systems validation procedures, templates, and documentation practices across division manufacturing and laboratory facilities
• Support implementation and maintenance of validated computerized systems to ensure compliant, reliable, and available systems that support product quality and business continuity
• Author, review, execute, and approve CSV lifecycle documentation, including:
• Ensure computerized systems remain in a validated state through effective management of:
• Participate in system risk assessments and help define validation strategies based on system complexity, intended use, GxP impact, and regulatory expectations
• Support data integrity assessments and compliance activities aligned with applicable requirements for electronic records, electronic signatures, audit trails, system access, backup/recovery, and security administration
• Partner with IT, Automation, Quality, Engineering, and system owners to support implementation, qualification, and lifecycle management of systems such as:
• Support supplier assessment and qualification activities for software vendors, service providers, and third-party system integrators as required
• Participate in internal, customer, and third-party audits and inspections, and support audit readiness for computerized systems compliance
• Support investigations, root cause analysis, and remediation efforts related to system issues, nonconformances, and validation gaps
• Drive continuous improvement in CSV processes, validation efficiency, template standardization, and inspection readiness
• Support new system implementations and upgrades, including validation impact assessments, test strategy development, and release to operational use
• Leverage risk-based validation methodologies and applicable lifecycle frameworks to support compliant and efficient validation activities
• Provide technical guidance to cross-functional team members on CSV requirements, system compliance expectations, and validation deliverables
• Support the creation and maintenance of technical documentation that meets business needs and complies with applicable international standards and regulatory requirements (e.g. FDA, EU, ISO, GAMP, ALCOA+)
• Ensure validation deliverables are inspection-ready, accurate, complete, traceable, and aligned with internal quality system requirements
• Lead CSV projects of moderate scale and complexity
• Participate in and sometimes lead validation activities on larger-scale system implementation or remediation projects
• Some travel is required as part of the job responsibilities

Experiences/Education - Required

• Bachelor’s degree in a technical or scientific field
• 1–2 years of experience in CSV, quality, IT systems, or regulated environments
• Working knowledge of GxP and validation lifecycle (IQ/OQ/PQ)Understanding of risk-based validation and data integrity (ALCOA+)
• Familiarity with change control, deviations, CAPA, and audit readiness
• Exposure to systems such as ERP, LIMS, MES, SCADA, or eQMS
• Strong attention to detail and technical documentation skills
• Analytical thinker with problem-solving and risk-based decision-making ability
• Effective communicator with strong collaboration skills
• Able to manage multiple tasks and work independently

Desired Experience & Skills

• Life Science or Pharmaceutical Packaging product application knowledge and experience.
• Injection Molding manufacturing process knowledge and experience.
• Certified Quality Engineer recognition by ASQ.
• Certified Green or Black Belt recognition by ASQ.