Title:  Sr Technical Writer

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:

In this role, you will generate, format and route:

• Clear, error-free and accurate standard documentation

• High-quality, easily understood technical documents, meeting minutes and presentations
• Procedures and other documentation according to all internal SOP’s and guidelines
• Work directly with Engineering and Operations Teams to effectively manage the validation of new equipment, existing equipment, and production processes  

Essential Duties and Responsibilities:

• Work in a team atmosphere to produce and maintain timelines on document deliverables for medical devices.
• Plan, develop, organize, write, edit and review operational procedures and validation documentation.
• Adhere to quality management system regulations and guidelines.
• Analyze documents to maintain continuity of style of content and utilize good documentation practices.
• Study products and processes and consult subject matter experts to gather data.
• Utilize software to route and control documents for revisions and approval of technical literature.
• Ability to travel as required for meetings and produce meeting minutes in professional format.
• Communicate appropriately with customers (internal and external) to determine documentation requirements.
• Coordinate with vendors to maintain project timelines.
• Collaborate with, and when necessary, manage site resources to ensure timely and successful validation of new equipment and processes
• Develop documentation across multiple projects and teams simultaneously.
• 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
• Other duties as assigned

Basic Qualifications: 

• Bachelor’s Degree related to Technical Writing or equivalent experience
• 3-5 years’ experience working in a technical writing position
• High level of proficiency in MS Office

Preferred Knowledge, Skills and Abilities:

• 1 year experience in manufacturing environment and understanding of good manufacturing practices
• 3 years’ experience in manufacturing environment and understanding of good manufacturing and regulatory compliance within an FDA certified facility
• Understanding of Lean Manufacturing
• Green Belt Certification
• Technical understanding of general equipment functionality
• Motivated to learn and grow within West, and develop the position as a Validation Engineer   

Travel Requirements:

• Limited travel may be necessary

Physical & Mental Requirements:

• Ability to work on location and operate equipment or gown as needed

Competencies/Authorities

• Non-US only where required for certain levels

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.