Senior Computerized System Validation (CSV) Specialist to provide technical leadership and compliance support for computerized systems within a regulated pharmaceutical manufacturing environment.
Responsibilities
Lead and execute Computerized System Validation (CSV) activities for computerized systems supporting manufacturing, sterile and non-sterile operations, laboratories, packaging, inspection, utilities, and facilities.
Develop, review, and execute computer system validation strategies, validation plans, protocols, test scripts, and supporting documentation.
Establish and maintain an effective CSV program aligned with applicable regulatory requirements, corporate standards, and site quality procedures.
Serve as the technical Subject Matter Expert (SME) for IT Compliance, Computerized System Validation, Data Integrity, and electronic records requirements.
Ensure computerized systems are appropriately validated and compliant before being released for their intended use.
Requirements
Bachelor’s degree in science, Computer Science, Engineering, Information Systems
Provide validation and documentation support for Manufacturing Execution Systems (MES) and Electronic Batch Records (eBRs) in a regulated pharmaceutical manufacturing environment.
Responsibilities
Develop, review, update, execute, and maintain computerized system validation documentation in accordance with GMP regulations and data integrity principles.
Support validation lifecycle documentation including URS, Functional Specifications, Design Specifications, Configuration Specifications, Risk Assessments, and Traceability Matrices.
Develop and execute IQ/OQ testing protocols and document validation results.
Coordinate activities with cross‑functional technical and business teams.
Prepare and review validation reports and summary reports.
Requirements
Bachelor’s degree in engineering, Computer Science, Information Technology, Life Sciences, Chemistry, or a related technical discipline
Nice to have: Syncade Enterprise MES (EMES)
Nice to have: Electronic batch record implementation
Responsible for administering, maintaining, and continuously improving Apnimed's electronic Quality Management System (eQMS) and associated quality processes, ensuring inspection readiness and supporting regulatory compliance.
Compensation
The expected annual base salary range for this role is $170,000.00 to $190,000.00.
Responsibilities
Serve as subject matter expert and administrator for the electronic Quality Management System (eQMS), evaluating proposed system changes and coordinating testing, validation, and deployment activities.
Support the integration of new business processes, departments, and vendors into the Quality Management System, and oversee onboarding, knowledge transfer, and competency requirements for new eQMS administrators.
Maintain system documentation, including procedures, work instructions, validation documentation, and configuration records.
Administer the training program: confirm assignments and curricula reflect quality system responsibilities, manage role-based eQMS training and user support, and maintain a centralized library of user guidance, job aids, and FAQs.
Provide oversight and support for core quality processes, including document control, deviations, CAPAs, change controls, investigations, supplier quality records, and training management.
Requirements
Bachelor's degree or equivalent in a scientific, technical, engineering, quality, or related discipline.
The Director Digital Quality Transformation is responsible for leading the modernization of Quality systems, processes, and governance frameworks that enable digital innovation, operational excellence, and sustainable business growth across Sharp's U.S. operations.
Responsibilities
Develop and execute a multi-year Digital Quality roadmap aligned with Sharp's business strategy
Establish Quality governance frameworks for digital quality systems across the enterprise
Support the integration of digital platforms and data architectures
Serve as the Quality representative and advisor for enterprise digital transformation initiatives
Champion the adoption of modern quality practices leveraging digital technologies, automation, and AI
Lead internal team members, suppliers, OEMs, system integrators, Digital/IT partners, automation-system owners, and cross-functional stakeholders to deliver OT infrastructure, industrial networking, integration, historian, virtualization, cybersecurity, and lifecycle initiatives in a cGMP manufacturing environment.
Responsibilities
Lead internal team members, suppliers, OEMs, system integrators, Digital/IT partners, automation-system owners, and cross-functional stakeholders to deliver OT infrastructure, industrial networking, integration, historian, virtualization, cybersecurity, and lifecycle initiatives in a cGMP manufacturing environment.
Own vision requirements and inspection specifications across filling, AVI, device assembly, and packaging.
Define inspection scope and measurable acceptance criteria with Quality and equipment specialists, resolving supplier and integration gaps.
Specify, configure, and troubleshoot cameras, lenses, illumination, exposure, triggering, and image geometry.
Develop and maintain inspection jobs for particle and cosmetic defects, container and closure features, component presence and orientation, print verification, and barcodes.
Requirements
Bachelor’s degree in Automation, Electrical Engineering, Computer Engineering, Computer Science, Optical Engineering, or a related technical discipline
Nice to have: robotic handling
Nice to have: automated setup
Nice to have: vision-guided verification
Nice to have: MES
Principal Automation Engineer Optical Inspection SME
6084-Janssen Research & Development Legal Entity · Posted Nov 6, 2026
Senior Automation Engineer will lead internal team members, suppliers, OEMs, system integrators, Digital/IT partners, automation-system owners, and cross-functional stakeholders to deliver OT infrastructure, industrial networking, integration, historian, virtualization, cybersecurity, and lifecycle initiatives in a cGMP manufacturing environment.
Responsibilities
Lead internal team members, suppliers, OEMs, system integrators, Digital/IT partners, automation-system owners, and cross-functional stakeholders to deliver OT infrastructure, industrial networking, integration, historian, virtualization, cybersecurity, and lifecycle initiatives in a cGMP manufacturing environment.
Own vision requirements and inspection specifications across filling, AVI, device assembly, and packaging.
Define inspection scope and measurable acceptance criteria with Quality and equipment specialists, resolving supplier and integration gaps.
Specify, configure, and troubleshoot cameras, lenses, illumination, exposure, triggering, and image geometry.
Establish stable image acquisition across product formats, equipment speeds, and expected variation in materials and presentation.
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