Labcorp is seeking an onsite Lab Systems Support Administrator tojoin our new CMC facility in Mechelen, Belgium.
Job Responsibilities:
1. The position will function on a regional level and global level
2. Act as an application SME resource for end users
3. Provide technical troubleshooting support and issue resolution for assigned computer applications and associated lab instruments
4. Lead and co-ordinate resolution to technical and business process issues as related to assigned computer applications
5. Influence System Lifecycle Specialists on a regular basis to ensure smooth and appropriate transition of new computer applications.
6. Lead business meetings where appropriate to ensure business user’s needs are being met.
7. Document discussions, issues, recommendations, and resolutions related to supported applications
8. Communicate technical issues and resolutions with users and share information with the Business Unit
9. Understand and maintain a high level of functional subject matter expertise and help to manage changing requirements
10. Responsible for training or confirming training of users in assigned computer systems
11. Work with users to fine tune functionality
12. Optimize business processes and application functionality
13. Work with users to expand deployment of applications to other departments and business units
14. Assists Manager with process to ensure a coordinated and unified approach for all managed applications
15. Perform other related duties as assigned
Regulatory Focused
16. Manage user access to the application including addition, modification, review, and removal of accounts as appropriate
17. Perform periodic reviews of user access
18. Establish, track, and maintain errors and performance in change control forms and logs
19. Provide application documentation for client and regulatory audits
20. Ensure responses to audit findings are completed as assigned by IT Compliance
21. 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
22. Write, approve, and perform qualification and other testing required to ensure application functionality
23. Archive validation documentation
24. Create, manage, and archive application documentation and data
25. Work with users to generate and review Application SOP’s
26. Work with users to create, review, and update application user manual(s) and System Usability Documents (SUD)
IT Focused
27. Help develop efficient and effective processes to ensure good communication between the business units and Information Technology (IT) staff.
28. Manage escalation of technical issues to IT
29. Manage escalation of issues to application vendors
30. Maintain application configurations which can be controlled within the application
31. Assist in retirement and/or decommissioning of applications
32. Ensure updates are made to the global systems inventory for applications
33. Coordinate release of new versions of the application into production including completing the Release into Production Checklist
34. Develop business scenarios to test the application
35. Verify installation and operation of the application
36. Document analysis and/or testing related to infrastructure changes. (e.g. operating system patches, significant network changes)
37. Participate in validation projects for assigned applications (e.g. requirements analysis, validation and regression testing, process analysis, deployment)
38. Create and maintain change control forms and logs
39. Interfacing and qualification of instruments to the application and first line support for instruments/instrument controllers
Minimum Qualifications:
40. BSc (Hons) scientific degree
41. 2 or more years experience
42. 3 or more years of experience working with MS Word, MS Excel, computerized data acquisition systems
Preferred Qualifications:
43. Degree in Biology or (bio)Chemistry
44. 2 or more years of experience in an IT systems support role in a GLP or GMP environment
45. 1 or more years of experience with scientific applications like Chromeleon, Softmax Pro, SoloVPE, PharmSpec, Veeva.
Additional Job Standards:
46. Knowledge of laboratory operations, study design and equipment used in lab environment.
47. Knowledge of business processes and of main data collection and analysis applications (i.e. NG/Pristima and Tox Reporting).
48. Knowledge of GXPs and regulatory agency guidelines.
49. Knowledge in the management of small business projects
50. Fluent knowledge of English and Dutch
51. Requires attention to detail and strong organizational skills.
52. Demonstrated ability to interact effectively with all staff and management levels.
53. Demonstrated problem solving and decision making skills.
54. Ability to work as a productive, contributing team member.
55. Possess strong communication skills
56. Ability to follow priorities and timelines
57. 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.
Labcorp is proud to be an Equal Opportunity Employer:
Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.
We encourage all to apply
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