Reference #: 1026187701The role is onsite in nature with hybrid possibilities. Candidates applying must be within 50 miles radius of the job location.Who We Are:At West, we're a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?There's no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.Job Summary:The principal architect will lead a global team to provide Laboratory D&T support, implement server-based systems, and maintain compliance. This person will provide strategic roadmap for LIMS implementation for GMP and non-GAP labs within West. He/She will also work closely with lab equipment support team, digital quality team and lab QA team to coordinate any global computer validation policy and work instructions. The global team will work with laboratory stakeholders to:understand complex system requirementsdeploy features and enhancements based on requirementsidentify process gaps and implement solutions to close the gapincrease efficiency and improve lab workflow processplay pivotal role in global lab digitization journeyEssential Duties and Responsibilities:Lead a global D&T team to administer and support server-based Laboratory applications (e.g. LIMS, SDMS, ELN/LES and Empower), and lab equipment software to ensure systems are operational.Strategically collaborate with groups within D&T (infrastructure, cybersecurity, etc.) and across the organization (QA and Lab) to ensure global infrastructure support for lab computer systemsWork with leadership team to plan for major key initiatives including lab automation, compliance and digitization.Maintain server-based systems in the lab to be compliant with cGXP and all data integrity standards to control costs, reduce risks and improve productivity.Primary subject matter expert for Laboratory Information Management System (LIMS) system.Evaluate data generated and/or stored within the system to provide ad hoc and long-term reporting solutions that address business needs and identify process gaps.Implement and maintain an efficient solution for backup, archiving and restore of electronic raw data on computer systems in the lab.Mentor and grow D&T lab support team members for server-based and integrated computer system supportResponsible for the availability and performance of global server-based computer systems used in labs (including, but not limited to, LIMS, SDMS, Empower, etc.)Drive continuous improvement process from technology-side using best industry practiceResponsible for the updated inventory list of laboratory computerized systems globally.Write, execute IQs, OQs, PQs, and validation protocols, as necessary.Initiate and review documents such as laboratory investigations, work instructions, SOPs, etc, as assigned.Research, recommend, develop and/or implements new software/upgrades and systems to increase compliance and efficiency in all laboratories.Ensures that new systems and software are properly integrated with existing processes and capabilities.Participate in rotating "on-call" support. This includes coordinating support with the softw re vendors as needed.Keep current with new technologies and cGXP regulations, including Data integrity.Has an in-depth understanding of and can communicate/educate the team on the Digital &Transformation related requirements to achieve and maintain cGXP and Data Integrity compliance.Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules. Assist with audits from both clients and regulatory agencies.Act as a global point of contact to coordinate the harmonization of lab applications to improve compliance and operational efficiency.Perform other duties as assigned.Education and Experience:Bachelor's degree or equivalent experience in Laboratory systems or a Scientific field.8+ Years of experience of managing Laboratory systems.Knowledge, Skills and Abilities:Manage global team within D&T (matrix or direct)Extensive project management experience, especially in biotech/pharma industryExperience with implementing and managing laboratory computer systemsKnowledge of cGMP regulations, and validating cGMP computer systemsKnowledge of the software development lifecycleExcellent communication skillsAble to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job DescriptionSupport and contribute in Lean Sigma programs and activities towards delivery of the set targetAble to comply with the company's safety policy at all timesList any safety requirements applicable to role within your countryPhysical and Travel RequirementsTravel up to 25% of the time#LI-DJ1West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and/or drug screening.

　　West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.  If you have a disability or special need that requires accommodation, please send an email to [email protected].