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Automation Specialist QC
Automation LIMS analytical software GAMP5 GMP
JobCLS Services is a leading professional recruitment agency specialised in chemistry & life sciences.
For our client Janssen Biologics B.V. we are searching for an Automation Specialist QC.
- Computerised Systems (GMP)
- Analytical software
- GAMP5/21CFR Part11
Data Integrity is very important, therefore, user requirements of (current and new) systems need to be translated into technical specifications and systems need to follow the set DI standards. Next to that (standard) data definitions still need to be developed to establish quality and data integrity expectations. Compliance to those expectations need to be ensured.
As automation specialist, you will play an important role in translating documented testing requirements into system configuration. As a member of the automation team, you have the shared responsibility to be compliant with the GMP regulations. You will act as a bridge between the product managers, laboratory technicians and local or global automation platforms.
Depending on your personal preference, your role can be in the development team, the lab support team or both. In this position, you are working in one, two, or three of all our focus areas. The following tasks and responsibilities describe the four focus areas:
Lab Support team member
- You are responsible for installing and configuring software and hardware on (Computerised) Analytical Systems;
- you are responsible to support the laboratory analysts in several tasks including troubleshooting issues and outages, creating methods, providing access control by setting up accounts and workstations, all related to laboratory systems;
- You are responsible for ensuring security and efficiency, through access controls, backups, audit trail reviews and firewalls within the QC labs next to managing servers and technology tools;
- You will develop expertise to train the lab operators and others on new technologies;
- You will build, and maintain together with the other team members, a internal SharePoint for frequently asked questions, documentation, manuals and other items;
- You will be part of several (digitalisation) projects.
- Technical implementation of new systems within the organisation in collaboration with other teams. Lab systems vary from (standalone) analytical equipment to complex global platform projects which connect to LIMS (Laboratory Information Management Systems);
- Implementation of SDMS (Scientific Data Management System) and future new paperless opportunities;
- Documenting administrator procedures, technical installation procedures and maintenance procedures;
- Implementing local and global ICT requirements in close collaboration with the related ICT departments;
- Responsible for data integrity, including backup and (disaster) recovery;
- Documented qualification of implemented systems following documented procedures;
- Provide support in case of (computerised) problems;
- Implementation of equipment from a 21CFR Part 11 compliance perspective;
- takes part in Lab Systems initiatives and projects, in co-operation with the global organisation and in alignment with business needs.
- Development and delivery of validated analytical software templates following documented requirements within the QC Laboratories;
- Follow local and global procedures that are applicable to instrument and software validation;
- Documented verification and validation of analytical software templates, using User Requirement Specification (URS), Qualification Plans and Qualification Reports;
- Responsible for translating technical documents into software requirements, in close collaboration with the laboratory and Subject Matter Expert (SME);
- Provide support in case of analytical method related laboratory problems.
- Translation documented product specifications into LIMS requirements;
- Configuring the LIMS for release testing, in-process testing, environmental monitoring testing and raw material testing, paperless testing (iLABS);
- Act as a bridge between the product managers and the global LIMS system;
- Act as a bridge between the technicians and the global LIMS system;
- Solving (ad hoc) LIMS problems and finding solutions for exceptional user requirement.
ProfileA B.Sc. or M.Sc. degree in Life Sciences or Computer Sciences is required in combination with broad knowledge and experience in computerised (GMP) systems. Furthermore, you need to be able to manage multiple issues, organise activities, prioritise your tasks and maintain a clear line of communication within the multidisciplinary teams.
Other requirements are:
- Experience with GAMP5 and 21CFR Part 11 is desirable;
- Knowledge of analytical software and computerised systems;
- LIMS (developer) experience is considered as a plus;
- Experience with (Computer) System Validation in a GxP environment is considered as a plus;
- Experience with the following software is considered as a plus: Empower, Softmax pro, SDMS, Deskman, LIMS, 32Karat, TECAN, QuantStudio;
- Project management skills and good interpersonal skills;
- Written and oral communication skills in English;
- Analytical thinking and (technical) problem solving. Lean/Six Sigma experience is desirable.
- Pro-active, work independently, take actions in the absence of specific instructions, and can read and write protocols/reports, business correspondence and procedures.
Days of leave: 36
See here our other employment terms for this vacancy
Project for at least 1 year, extension possible
40% remote/ 60% on site
Company profileJanssen Biologics creates, acquires and markets unique biopharmaceutical therapies. Their innovative products focus on the management of three major disease areas; cardiovascular, immunological disorders and cancer.
They strive to be a prominent company. Not only by the marketing of important new products. They also effectuate to increase the applications of their existing products. This means investing in the right research, forging the right business partnerships and hiring the right people to maintain the highest quality.