Specialist QC system/equipment

Job description

Overview

Summary The QC Equipment and System Specialist plays a key role in supporting and maintaining Quality Control (QC) equipment and systems, with an emphasis on Laboratory Information Management Systems (LIMS) and associated analytical software tools, QC equipment selection, qualification and lifecycle management and computerized systems methods. The position involves cross-functional collaboration with QC, QA, and IT, and global stakeholders to ensure data integrity, system compliance, and operational efficiency.

The role requires deep expertise in QC equipment and associated softwares, LIMS QC processes implementation (preferably LabWare), strong project coordination skills, and the ability to translate QC user needs into effective technical solutions. The QC System Specialist drives system validation, process improvements, report customization, and contributes to new equipment implementation and data lifecycle management.

Key Responsibilities

Lead QC equipment selection via URS creation, support equipment qualification and lifecycle management and interface with internal stakeholders (Quality operations, Engineering, Calibration/Qualification). Coordinate with LIMS administrators and global teams to support system enhancements, issue resolution, and UAT reviews. Act as a key contributor in LIMS-related projects including new equipment and software implementations (Empower, SoftmaxPro, SoloVPE, …), from requirement gathering to technical execution and validation.

Lead or support validation of computerized systems including URS creation, protocol development, execution, and compliance documentation. Create, manage and maintain computerized systems methods and protocols. Actively lead and participate to QC digital/computerized projects and improvement (e.g. Custom Fields validation, Excel file validation) Interface with digital reporting systems (e.g., Power BI, MES/Skyland) to support integration and data visualization needs.

Manage and maintain reports and templates within LIMS and related software to meet QC operational needs. Support deviation investigations, change control (CC), and GxP documentation updates related to QC computerized systems. Drive implementation of streamlined new processes within LIMS according to project timelines. Ensure compliance of LIMS UAT processes and configuration changes. Liaise with stakeholders (QA, QC, IT, vendors) to ensure cross-functional alignment on system functionalities and regulatory compliance.

Act as the QC system SME during internal and external audits, providing technical documentation and explanations. Proactively identify system improvement opportunities and lead corrective/preventive actions related to QC systems.

Education and Experience

Bachelor's or Master’s degree in life sciences, IT, bioinformatics, or engineering. 5-10 years of experience in the biotechnology or pharmaceutical industry in a GMP-regulated environment. Proven hands-on experience with LIMS (preferably LabWare) and analytical software (Empower, SoftmaxPro, SoloVPE, etc.). Experience in system validation, project coordination, and regulatory compliance. Knowledge, Skills, Abilities Strong expertise in LIMS administration, technical configuration, and validation.

Strong expertise in QC computerized systems (e.g., Empower, SoftMaxPro) Solid understanding of GMP guidelines, data integrity, and computerized system validation (CSV). Excellent project coordination skills, especially in cross-functional environments (QC, QA, IT). Strong communication skills in English (written and spoken); ability to collaborate with US-based teams. Technical problem-solving mindset, capable of translating user requirements into structured technical solutions.

Proactive, self-driven, and comfortable taking ownership of complex topics. Strong leadership capabilities to drive system-related initiatives, report on progress, and influence stakeholders. Ability to manage multiple priorities while maintaining attention to detail and compliance.

Disclaimer

The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

We Respect Your Privacy Learn more at

http://www.incyte.com/privacy-policy The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate. During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here.

You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work. You can learn more about

Incyte’s data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte’s data protection officer, and your supervisory authority (if applicable).

Please contact [email protected] if you have any questions or concerns or would like to exercise your rights.