West Pharma Sr Sol Arch & Lab Solutions 

United States, Pennsylvania, West Whiteland Township 

105845959

Job Summary:

The Lab Services Senior 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.

Essential Duties and Responsibilities:

• Administer and support lab equipment software within the Exton 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

Basic Qualifications:

• Bachelor’s degree or equivalent experience in IT, Laboratory systems or a Scientific field or equivalent experience
• Minimum of five years of industry experience with at least two years of experience working with Lab Systems

Preferred Knowledge, Skills and Abilities:

• 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

Travel Requirements:

• Must be able to travel up to 5% of the time

Physical and Mental Requirements:

• Sedentary - exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to life, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met
• Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines
• Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read & write, speak in front of groups, express & exchange ideas, understand direction and adhere to procedures
• Organizational skills will enable planning, prioritization & achievement of goals especially of importance for the successful execution of related activities
• Position operates in a professional office environment. May stand or sit for extended periods of time
• Read and interpret data, information and documents
• Must maintain the ability to work well with others in a variety of situations
• Must be able to multi-task, work under time constraints, problem solve, and prioritize
• Ability to make independent and sound judgments
• Observe and interpret situations, analyze and solve problems