IT Engineering Specialist III (GXP Manufacturing & Labs)

Description

100% On site role

Actual Title: IT Engineering Specialist III

Location - Frederick, Maryland

Experience and Education:

• Master’s degree in Computer Science or Information Systems and 8+ years of industry experience OR
• Bachelor’s degree in Computer Science or Information Systems and 10+ years of industry experience OR
• Associate’s degree in Computer Science or Information Systems and 12+ years of industry experience

Responsibilities of the IT Engineering Specialist include, but are not limited to: 

• Responsible for the delivery of global, site-specific, and compliant IT solutions within the TechOps IT portfolio and provide operational support.
• Ensure delivery of IT solutions to QC labs, R&D labs, and manufacturing.
• Perform installation, configuration, support, and administration of computer systems and lab instruments in a regulated GMP environment.
• Provide maintenance and support requests to address IT operational issues on assigned technologies, following established processes and procedures.
• Collaborate with business groups, vendors, and cross-functional teams to deliver innovative, scalable, and compliant IT solutions.
• Document user and functional requirements.
• Support IT architecture by working closely with enterprise architects and following established guidelines. Present solutions’ architecture the architecture review board.
• Design and implement site specific, regional, global, enterprise, and other IT solutions. Author detailed design specifications, architecture and data flow diagrams.
• Author and execute test scripts. Work with vendors and quality teams on authoring and execution of IQ/OQ/PQ to qualify IT solutions.
• Follow SDLC, PMM, Agile and other methodologies for projects and systems delivery.
• Work closely with project managers and the PMO on scheduling and monitoring progress of initiatives. Provide project tasks estimates Contribute to the discussions about resource allocation and capacity planning.
• Address project constraints, including risks and issues. Follow project change control for managing scope and schedule.
• Collaborate with internal & external stakeholders to diagnose and resolve IT issues.
• Ensure the availability and functionality of both hardware and software systems for daily operations, providing technical support on-site or remotely when necessary.
• Manage changes in accordance with GxP and IT change control processes, ensuring SLAs and KPIs are consistently met.
• Stay aligned with domain architecture teams to ensure global consistency, influencing changes to standards when needed.
• Document process steps and systems enhancements required to support process
• Engage with internal clients and stakeholders to address issues with quality and manufacturing systems.
• Analyze security protection technologies, adhering to Corporate IT security policies and guidelines.
• Develop a deep understanding of the business processes and all applicable procedures
• Foster strong relationships with clients and stakeholders.
• Ensure alignment between manufacturing sites and corporate IT for global consistency.

Qualifications:

• Experience with quality labs and manufacturing instruments, IT solutions, operating systems, security concepts, infrastructure, and systems’ configurations and customization.
• Previous experience working in a GxP environment supporting biotech/pharma technology solutions.
• Strong knowledge of commissioning, qualification, and validation processes.
• Experience with system integration and the ability to engage with stakeholders at all levels in an international environment.
• Demonstrated ability to work under indirect supervision and managing multiple competing priorities concurrently.
• Strong planning and execution skills, with a systematic approach to problem solving.
• 5-7 years of experience related to IT systems management, IT operational support or other information technology solutions roles, ideally in an international setting.
• Excellent oral and written communication skills.
• Strong analytical and problem-solving skills.
• High attention to detail in both technical and administrative tasks.
• Broad knowledge of IT topics, with proficiency in working in a secure network environment.
• Resilience and adaptability to perform effectively in an ambiguous and high-pressure environment.
• Honest and credible, and effective in communication.