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West Pharma Solutions Architect Digital & Transformation Lab Support Ireland, Waterford 815103199
17.04.2025
Job Summary
- The role is part of a Digital and Transformation (D&T) Team.
- The role will be primarily responsible for administrating, supporting and implementing lab instrument software within Analytical Labs focused on Waterford and other EU locations.
- Additional responsibilities will include working with sever based laboratory applications (LMS, SDMS and Empower) as needed.
- 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 while maintainingapplicable regulatory requirements (i.e., cGMP, Computer System Validation, 21 CFR part 11 compliance).
Essential Duties and Responsibilities
- Administer and support lab equipment software within the Waterford Analytical Services to ensure systems are operational
- Work with server based lab applications such as LMS, SDMS and Empower which are directly integrated with the equipment as requested.
- 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 change controls, CAPA's, laboratory investigations, work instructions, SOP’s, etc., as assigned
- Ensure that new systems and software are properly integrated with existing processes and capabilities
- Perform other tasks as assigned
Education
- Bachelor’s degree or equivalent experience in IT, Laboratory systems or a Scientific field
Work Experience
- Minimum 3 years of experience of IT support and / or IT operations, ideally in regulatory manufacturing environment
- Minimum of one year experience working with Lab Systems
- Experiences in collaboration within international teams a plus
Preferred Knowledge, Skills and Abilities
- Working knowledge of various analytical instruments software
- Experience working in cGMP compliant Analytical Lab with knowledge of Part 11 compliance and validation.
- Solid understand of PC Hardware, PC based networking and Microsoft Windows operating systems
- 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, Laboratory Monitoring System such LMS Pharma 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
- Support and contribute in Lean Sigma programs and activities towards delivery of the set target
- Able to comply with the company’s safety policy at all times.
- Able to comply with the company’s quality policy at all times.
License and Certifications
- ITIL Foundations Certification, A+, COMP TIA, a plus.
Physical Requirements
Light-Exerting up to 20lbs/9kg of force frequently, and/or negligible amount of force frequently constantly to move objects.
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