Lab Systems Senior Specialist

Job purpose:

As Lab Systems Senior Specialist:

• You ensure prioritisation of operational activities according to Business requirements and available capacity within the team (GSK staff as well as external workforce).

• You ensure efficient and effective coordination of activities with the Functional Services Provider, including definition of guidelines on the expected technical solutions to be delivered.

• You will be responsible for the definition of IT/OT network integration strategies for R&D computerized systems, in line with GSK Tech rules and policies, based on business requirements and following QA recommendations.

• You will be accountable for the software configuration by the team’s technicians and possibly of the operating system to ensure compliance of the computerized systems and the integrity of the generated data.

• You ensure the systems’ Life Cycle Management by continuously improving and documenting support model, maintenance strategy, but also recovery plans for system and data.

• For systems used in a regulated (GxP) environment, you define and approve, as Technical Owner, the Integration, Configuration and Life Cycle Management (more than 250 "Level-3" lab systems in R&D Belgium).

• You will lead and coordinate activities such as Periodic reviews, Services Catalogue upgrades, Change Management, etc.

Your responsibilities:

With a high degree of autonomy and in a team of IT-skilled profiles, dedicated to the management of computerized lab systems:

• You review/analysis of user requirements and computerized systems specifications prior to equipment purchase. Provide technical recommendations and highlight integration and/or configuration constraints based on Tech, CSV and Data integrity rules and policies

• For new computerized systems, define the best network integration strategy in collaboration with the equipment supplier, Tech, QA and CSV

• You embed Cyber Security into all new solutions and ways-of-working

• You communicate & share detailed knowledge of best practices & current trends, acquired both internally & externally, for instance on - but not limited to - Cyber Security Threats and Protection

• You lead integration of complex Client-Server solutions, cross-platforms such as Chromatography systems (Empower, Unicorn, etc.)

• You ensure creation of integration and configuration documents: Design specifications, Installation Scenario, Post-Installation Guide the activation/ configuration of specific modules such as Access Management, Audit Trail, etc. in collaboration with business, QA and CSV

• You define and document “Systems’ Life Cycle Management” aspects, such as; Maintenance and Support Model, “Back-up and Restore plan” for the data, “Disaster Recovery Plan” for the system, Obsolescence management (upgrades, migrations, replacements)

• You review/approve “qualification/validation documentation” of R&D Computerized Systems

• You create WKI and other guidance documents in the field of expertise (Lab Systems Integration, Analytical Software Configuration, Setup and application of Cybersecurity mitigations and standards)

• In the context of the Data Integrity program in R&D, ensures the feasibility and detailed definition of the technical mitigations to put in place for non-compliant Computerized Systems (backlog)

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor or University level or equivalent by experience in IT Integration, IT Support, IT Infrastructure, IT Services (ITIL) or Cyber Security

• Expertise in defining network integration solutions for computerized lab systems

• Strong experience with Lab and IT activities, advanced knowledge in IT Infrastructure and IT Risks and Compliance aspects

• Experience and advanced knowledge in industry standards and practices, in the field of Cyber Security (International Society of Automation, National Institute for Standards and Technologies)

• Proven experience in the field of analytical lab equipment (GAMP, CFR 21)

• Robust Experience with Quality Assurance in pharmaceutical environment.

• Fluen in French and good knowledge of English

Preferred qualifications:

If you have the following characteristics it would be a plus:

• Highly comfortable with working in a diverse, ambiguous and a fast-paced environment.

• Ability to manage Risks, define risk-based strategies.

• Ability to challenge and debate issues.

• Ability to look at situations from several points of view.

• Ability to quickly assimilate facts and data and develop an understanding of complex matters.

• Li-GSK

Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork in a culture of Innovation, Performance and Trust.

GSK Vaccines – Our Vaccines business has a broad portfolio and innovative pipeline of vaccines to protect people of all ages. We deliver over two million vaccine doses per day to people living in over 160 countries.

For further information, please visit www.gsk.com.

Quality Belgiummanages all product quality related activities in industrial operations in Belgium, including regulatory compliance. The scope covers any action that potentially impacts final product quality. Quality Belgium is also responsible for the quality control and the release of final products made in Belgium.

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.

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