Laboratory IT Systems Specialist

Job Responsibilities:

• The position will function on a regional level and global level
• Act as an application SME resource for end users
• Provide technical troubleshooting support and issue resolution for assigned computer applications and associated lab instruments
• Lead and co-ordinate resolution to technical and business process issues as related to assigned computer applications
• Influence System Lifecycle Specialists on a regular basis to ensure smooth and appropriate transition of new computer applications.
• Lead business meetings where appropriate to ensure business user’s needs are being met.
• Document discussions, issues, recommendations, and resolutions related to supported applications
• Communicate technical issues and resolutions with users and share information with the Business Unit
• Understand and maintain a high level of functional subject matter expertise and help to manage changing requirements
• Responsible for training or confirming training of users in assigned computer systems
• Work with users to fine tune functionality
• Optimize business processes and application functionality
• Work with users to expand deployment of applications to other departments and business units
• Assists Manager with process to ensure a coordinated and unified approach for all managed applications
• Perform other related duties as assigned

Regulatory Focused

• Manage user access to the application including addition, modification, review, and removal of accounts as appropriate
• Perform periodic reviews of user access
• Establish, track, and maintain errors and performance in change control forms and logs
• Provide application documentation for client and regulatory audits
• Ensure responses to audit findings are completed as assigned by IT Compliance
• Validate and perform user testing including the process design tests to challenge the software, and documenting results/installations as required by GLPs and/or SOPs
• Write, approve, and perform qualification and other testing required to ensure application functionality
• Archive validation documentation
• Create, manage, and archive application documentation and data
• Work with users to generate and review Application SOP’s
• Work with users to create, review, and update application user manual(s) and System Usability Documents (SUD)

IT Focused

• Help develop efficient and effective processes to ensure good communication between the business units and Information Technology (IT) staff.
• Manage escalation of technical issues to IT
• Manage escalation of issues to application vendors
• Maintain application configurations which can be controlled within the application
• Assist in retirement and/or decommissioning of applications
• Ensure updates are made to the global systems inventory for applications
• Coordinate release of new versions of the application into production including completing the Release into Production Checklist
• Develop business scenarios to test the application
• Verify installation and operation of the application
• Document analysis and/or testing related to infrastructure changes. (e.g. operating system patches, significant network changes)
• Participate in validation projects for assigned applications (e.g. requirements analysis, validation and regression testing, process analysis, deployment)
• Create and maintain change control forms and logs
• Interfacing and qualification of instruments to the application and first line support for instruments/instrument controllers

Minimum Qualifications:

• BSc (Hons) scientific degree

• 2 or more years experience

• 3 or more years of experience working with MS Word, MS Excel, computerized data acquisition systems

Preferred Qualifications:

• Degree in Biology or (bio)Chemistry

• 2 or more years of experience in an IT systems support role in a GLP or GMP environment

• 1 or more years of experience with scientific applications like Chromeleon, Softmax Pro, SoloVPE, PharmSpec, Veeva.

Additional Job Standards:

• Knowledge of laboratory operations, study design and equipment used in lab environment.
• Knowledge of business processes and of main data collection and analysis applications (i.e. NG/Pristima and Tox Reporting).
• Knowledge of GXPs and regulatory agency guidelines.
• Knowledge in the management of small business projects
• Fluent knowledge of English and Dutch
• Requires attention to detail and strong organizational skills.
• Demonstrated ability to interact effectively with all staff and management levels.
• Demonstrated problem solving and decision making skills.
• Ability to work as a productive, contributing team member.
• Possess strong communication skills
• Ability to follow priorities and timelines
• Ability to work independently, with a study team, and lead small teams.

Labcorp is expanding its global BioPharmaceutical Chemistry, Manufacturing and Control (CMC) footprint and is opening a new CMC facility in Mechelen, Belgium.

This position will provide technical computer support, including problem solving, tracking, and issue resolution. The position will include application administration support across LabCorp Business Units in coordination with multiple Computer Application Support/Application Administrator positions. 

Biopharmaceutical CMC provides independent, objective GMP analytical testing for manufactured medicinal products from late discovery through post-market approval on behalf of global clients.  With a strong portfolio of clients and over 25 years of expertise the BioCMC team provides advanced characterization, method development, stability and routine QC release for biologics, vaccines, ATMP’s, and a breadth of other complex biomolecules. 

With this new laboratory in Belgium, we aim to offer a more comprehensive solution and accelerate the availability of new products for patients. The new site has been strategically developed to complement our existing capabilities in York and Harrogate (UK), and Greenfield (US) and introduce a new CMC analytical testing solution for commercial drug products in the European Union (EU).

This expansion is a key milestone in our long-term plan to strengthen support for pharmaceutical and biotechnology partners who rely on Labcorp for complex CMC and regulatory testing services. If you would like to join us and be a part of this exciting journey, take a look at the fantastic opportunities we have to offer.