Computer System Validation Manager Jobs in Waukegan, IL

• Own the full lifecycle of assigned applications — configure, develop, install, deploy, and maintain the application, database, configuration, and licensing. (Standard desktop productivity software such as Microsoft Office, Visio, and Project is excluded and managed by the IT infrastructure/operations team.)
• Provide application administration and validated-system support for software-controlled systems — including but not limited to MasterControl, LabX, Empower, NuGenesis, and other quality/laboratory instrument data systems — including onboarding new products, methods, and reporting templates, and adding or removing instruments in coordination with the IT team.
• Routinely monitor application and data-system health using checklists, logs, alerts, and monitoring tools, and lead debugging and troubleshooting of application issues, escalating infrastructure-level issues to the appropriate IT teams.
• Serve as the primary technical point of contact, with the IT infrastructure team, for server or system changes affecting quality operations (e.g., Active Directory, server/software updates, IP address changes, backups); coordinate and validate quality impact, but do not perform Server OS, hardware, or VM administration.
• Manage all user access to assigned applications and perform the required user, access-log, and audit-trail reviews for GxP-relevant systems.
• Verify that backup and restore procedures are properly configured and functional (e.g., database dumps, Veeam/Commvault) and maintain readiness to restore primary applications following a disaster.
• Maintain complete application documentation — workflow diagrams, baseline and current configuration, operating procedures/SOPs, scope, requirements, purchase, licensing, maintenance, and technical-support records.
• Manage vendor relationships for assigned applications and equipment, including support contracts, maintenance agreements, upgrades, and project deliverables.
• Support the full computerized system validation lifecycle (IQ/OQ/PQ) and adhere to change control for all application changes — including impact assessment, documentation, validation/revalidation, and CAPA execution with effectiveness verification.
• Perform periodic system analysis and drive upgrades and process improvements; contribute to a multi-year roadmap addressing technical debt and system/equipment obsolescence.
• Maintain the IT Service Desk system according to the standards set by IT management.
• Coordinate network, cybersecurity, and infrastructure activities with the appropriate teams.
• Support and participate in internal and external audits (e.g., FDA and customer), including responses to observations.
• Identify, evaluate, and manage risk to product quality, and maintain the effectiveness of the Quality System components relevant to this position.
• Other duties as assigned.

• Bachelor's degree in Information Technology, Chemistry, Engineering, or a related discipline. Master's degree a plus.

• 5–7 years of Quality data systems administration and/or IT experience, including a minimum of 5 years in a cGMP environment; pharmaceutical or related industry preferred.
• Functional and technical knowledge of systems such as Waters Empower, Waters NuGenesis, LabX, Novatek LIMS, and MasterControl; knowledge of laboratory instruments/processes such as HPLCs, UV, and titrators a plus.
• Experience with CSV, GAMP, data integrity, 21 CFR Part 11 compliant systems, and regulatory/customer audits.
• Working familiarity with server operating systems, server hardware, and virtualized (VM) environments; knowledge of TCP/IP highly desirable.
• Strong understanding of SQL databases, queries, and reporting solutions.
• Knowledge of current cGMP, FDA, and other regulatory requirements; SOP writing and/or training experience a plus.
• Strong ability to analyze user requirements and build/source application-based solutions to specification, including implementation and systems integration between applications.

• Thorough understanding of server operating systems, SQL, Windows (7 through 11), web browsers (Edge, Firefox, Chrome), Office 365, Teams, assigned applications, and relevant development and administrative tools, plus a basic understanding of the network and cybersecurity environment.
• Follows trends and changes in the application administration and IT field, proactively recommending improvements and willingly learning and adopting new technologies.
• Self-motivated and able to work with minimal supervision, consistently delivering quality work within established timelines and procedures while multi-tasking and meeting deadlines.
• Strong strategic and analytical thinking, problem solving, and decision-making, with exceptional planning and organizational skills.
• Communicates clearly and concisely, both orally and in writing, and presents effectively to individuals and groups; demonstrated ability to read, write, and speak clear English.
• Demonstrated ability to author technical documentation for software-controlled and data acquisition/management systems, including plans, requirements, specifications, protocols, test cases, and summary reports.
• Establishes and maintains cooperative working relationships across cross-functional teams in a fast-paced, dynamic environment.
• Remains current in all aspects of cGxPs, SOPs, methods, and protocols.

• Ability to stand, sit, walk, climb a ladder, access all areas of the facility, use basic office equipment such as a personal computer and copier, and communicate via telephone regularly during the course of work. Work is normally performed in office and laboratory environments with partial time spent in the Production area.
• Occasional lifting and/or moving of up to 30 pounds.

Notice to Agency and Search Firm Representatives: Woodstock Sterile Solutions is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Woodstock Sterile Solutions employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Woodstock Sterile Solutions. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.