Project Specialist, D&T, IoT Product and Compliance

Contenuto del lavoro

Description

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

Job Summary

As part of the IoT application development team, theIoT Product & Compliance Mgt Specialist, Digital and Transformation participates in the design, development, and support of West IoT applications with a focus on the technical documentation requirements in the internal and external communication, processes, and compliance, primarily in English. Owning the documentation artifacts and processes, he/she will work with an international team to bring the power of IoT in the Pharmaceutical space, contributing to the validation and regulatory approval process for West’s IoT Applications in Health/Medical, Industry 4.0/Manufacturing Automation, and other areas.

Essential Duties And Responsibilities

• Responsible for the technical documentation requirements in various software development stages including development, maintenance, support, validation, and regulatory approval
• Prepare, review, revise, and maintain the technical documents for various development, marketing, and production purposes
• Gather, analyze, and create technical and product information from various sources for product documentation
• Support the team in various ISO and other standard certification
• Support the team with various documentation submissions for pattern, competition, and other purposes
• Other duties as assigned
  

Education And Experience

• Bachelor’s degree in English or technical field preferred
• 3+ years of technical writing, GxP validation, ISO certification, FDA approval, or related work experience
  

Knowledge, Skills And Abilities

• Excellent oral and written communication skills in both English and Mandarin
• Experience as a technical writer
• Experience in an Agile Software Development environment is a plus
• Experience with ticket tracking systems (eg. Jira or Azure DevOps)
• Good understanding of IoT space technologies
• GxP, medical regulatory, and ISO certification experience are a big plus
• Excellent organization skills with ability to organize task and team communication efficiently
• 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
  

Physical And Travel Requirements

• Less than 10% travel, including international and within Asia Pacific
• Flexibility to work with teams in different time zones (incl. Evening meetings)
  

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 Apply.Accommodation@westpharma.com . 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.