West Pharma Lab Services Solutions Architect 

Germany, North Rhine – Westphalia 

155543853

The Lab Services Solutions Architect, is part of a Digital and Transformation (D&T) Team will be primarily responsible for administrating, supporting and implementing lab instrument software and associated sever based platforms server based laboratory applications (LMS, SDMS and Empower) within Analytical Services. The Solutions Architect will work closely with other members of the D&T, QA, Metrology and Lab Operations to ensure these systems meet the needs defined by Global Analytical Services which include maintaining cGMP compliance

• Administer and support lab equipment software within the Analytical Services to ensure systems are operational
• Administer and support server based lab applications such as LMS, SDMS and Empower which are directly integrated with the equipment.
• Participate as in user management and daily application management activities associated with global Laboratory Information Management System(LIMS)
• Participate in the assigned activities which support the roll out of key initiatives for lab automation and compliance to the global site laboratories
• Participate in rotating “on-call” support to provide 24 hours/7 days/365 days per year application support. This includes coordinating support with the software vendors as needed.
• Maintain systems in a compliant environment to control costs, reduce risks and improve productivity
• Collaborate with Lab Operations and Metrology to ensure system needs within Analytical Services are communicated
• Write, execute IQs, OQs, PQs, and validation protocols as necessary
• Initiate and review documents such as laboratory investigations, work instructions, SOP’s, etc., as assigned
• Ensure that new systems and software are properly integrated with existing processes and capabilities
• Assist and participate in audits
• Perform other tasks as assigned

• Bachelor’s degree or equivalent experience in IT, Laboratory systems or a Scientific field or equivalent experience

• Minimum of three years of industry experience with at least two years of experience working with Lab Systems
• Minimum of one year experience working with Lab Systems

• Working knowledge of various analytical instruments software a must
• Experience working in cGMP compliant Analytical Lab with knowledge of Part 11 compliance and validation a must
• Solid understand of PC Hardware, PC based networking and Microsoft Windows operating systems a must
• ITIL Foundations Certification, A+, COMP TIA, MCSD, MCDBA, Oracle OCA or OCP, a plus
• Ability to work with staff, peers, and others in a fast pasted, team oriented, cross functional, multi-cultural environment to accomplish established goals and objectives as well as identify and resolve problems
• Shows initiative and ability to work independently
• Strong analytical, problem solving and decision-making abilities
• Excellent written and verbal communication skills required
• Working knowledge of any or all of the following applications Waters Nugenesis SDMS, Waters Empower, an LMS such as WebCtl or LMS Pharma a plus
• Experience with Oracle, various Microsoft products such as Microsoft SQL Server, Microsoft Application Development Tools a plus
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Able to comply with the company’s safety and quality policies at all times

• Information Technology\ITIL Foundations v3 preferred