For our client, a global pharmaceutical company, we are looking for an IT Manufacturing C&Q engineer.
The Company
Our client is a global biopharmaceutical company located near Neuchâtel, Switzerland
Focused on R&D and delivery of innovative medicines across several therapeutic areas, including oncology, haematology, immunology, and CVD.
The Role
Main Duties And Responsibilities For This Role Are
Explain and obtain Information Technology Requirements and Good Manufacturing Practice (GMP) regulations from the vendor. When necessary, customize the system or adapt the process to comply with GMP.
Guarantee data integrity of the system, its environment, and process.
Design, elicit, analyze, document, and validate detailed user, functional, and non‑functional requirements; identify gaps between system capabilities and requirements to ensure business needs are met.
Adjust the number of deliverables, their quality, and complexity to guarantee compliance with timelines and the validation approach.
Facilitate meetings with business colleagues on IT topics.
Assist in translating compliance requirements into test conditions and expected results for application functionality and acceptance testing (IQ, OQ, PQ, FAT, SAT).
Conduct factory acceptance testing (FAT) in EU countries.
Understand business objectives, processes, and strategies.
Drive development and execution of change management and training throughout the organization during the implementation and ongoing use of system applications.
Work strategically and independently with internal and external groups on multiple simultaneous projects.
Ensure the use of existing standards for design and governance.
Architect system‑specific topology and integrate it into the existing infrastructure.
Collaborate with IT groups to ensure standards are applied for technological tools.
Leverage existing standards to capitalize on lessons learned.
Define new versatile solutions covering abstract user requirements to fulfill unmet needs.
Implement standalone and interconnected computerized systems supporting production activities such as blending, encapsulation, tablet press, blistering, bottling, room monitoring systems, and other equipment used for manufacturing.
Apply a wide variety of IT skills to configure systems and implement backup mechanisms for flat files, databases, etc.; deploy proper privileges on the operating system (Windows) and file systems.
Develop governance and “how to” work practices, including configuration specifications, to enable the operational team to support and administer the newly integrated system.
Transmit information and follow up with specialists to obtain the configuration of the global network, backup tool, and infrastructure.
Configure and set up local network, infrastructure, computers, and applications.
Prepare and configure interfaces between multiple systems; use Kepware technology and OPC protocol as required.
Qualifications
Experience in the pharmaceutical, biotechnology, or life science industry.
3–5 years’ experience as an IT engineer running projects from requirements to delivery of final product, including documentation.
Familiarity with change‑management tools and regulated document authoring.
Experience with commercial off‑the‑shelf (COTS) and web‑based requirements, architecture, and Agile/Scrum methodology.
Experience with real‑time data management and interfaces (e.g., Kepware, OSI PI) is a strong plus.
Experience with Six Sigma, Lean, or business‑process‑change techniques is a plus.
Technical diploma in information systems or equivalent experience.
Experience in computer system validation.
Awareness of 21‑CFR Part 11, EudraLex, MHRA.
Awareness of business and enterprise architecture.
Fully operational in French and English.
Business acumen.
Autonomous in analysis, problem‑solving, and delivering results.
Strong oral and written communication skills.
Constructive influencing of colleagues to achieve a positive outcome.
Only applicants eligible to work in Switzerland (Swiss nationals, current Swiss work permit holders, or cross‑border EU citizens) will be considered.
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