Specialist, Product and Compliance

Description

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

As part of the IoT application development team, the IoT Product & Compliance Mgt Specialist, Digital and Transformation, participates in the design, development, validation, and support of West IoT applications with a focus on GxP-compliant computerized system documentation and processes, primarily in English. The specialist will be responsible for owning the documentation artifacts and ensuring alignment with Computerized System Validation (CSV) lifecycle requirements while maintaining compliance with regulatory expectations and West quality standards. Working closely with an international team, the individual will help drive the validation readiness and continuous improvement of West's GxP-relevant IoT applications within manufacturing and digital operations.

This position is offered as a one-year contract, with potential for conversion to a permanent role.

Essential Duties And Responsibilities

• Manage the document lifecycle for GxP computerized systems, covering design, development, testing, validation, release, and change control documentation
• Prepare, revise, and maintain technical validation deliverables such as Functional Risk Assessment (FRA), Functional Specification (FS), Design Specification (DS), Requirements Traceability Matrix (RTM) and relevant technical work instructions, ensuring alignment with GxP and data integrity expectations
• Collaborate with global cross-functional teams within the company, including Quality, Validation, Business and IT, to support CSV activities and ensure consistency with validation objectives and regulatory guidance
• Other duties as assigned

Education

• Bachelor's degree in English or technical field preferred

Work Experience

• 2+ years of experience in GxP computerized system documentation, validation support, or quality compliance roles within a regulated industry preferred

Preferred Knowledge, Skills And Abilities

• Excellent written and verbal communication skills in both English and Mandarin
• Solid understanding of GxP principles, CSV lifecycle, and associated documentation controls
• Ability to prepare, review, and manage system deliverables that demonstrate compliance with validation and quality requirements
• Experience with Agile software development practices and tools such as Azure DevOps or Jira is a plus
• Familiarity with IoT systems, automation platforms, or cloud-based applications in a regulated context is an advantage
• Working knowledge with GAMP 5, 21 CFR Part 11, and EU Annex 11 is a big plus
• Strong organizational skills with an ability to prioritize multiple deliverables and manage communications efficiently
• Ability to collaborate effectively in a global matrixed organization, bridging technical, business, and quality functions to ensure compliant system delivery
• Ability to work autonomously in a fast-paced and complex environment with a self-motivated work ethic; use sound judgment with an ability to manage multiple priorities with a sense of urgency
• Able to comply with the company's safety and quality policies at all times

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 special need that requires accommodation in order to apply to West, please send an email to [Confidential Information] . Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.