Full 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 Interact with a team of multiple subject matter experts to generate, review, update and route validation documentation. Act as a local expert for department teammates and technical writer staff in regard to requirements for documentation deliverable generation, requirements and routing across multiple manufacturing sites.Essential Duties and Responsibilities Plan, develop, organize, write, edit and review operational procedures and validation documentation.Communicate appropriately with customers (internal and external) to determine documentation requirementsClear, error-free and accurate standard documentationDevelop documentation across multiple projects and teams simultaneously.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.Generate and review a variety of manufacturing and inspection equipment validation deliverables, including, but not limited to: protocols, reports, specifications, manuals, work instructions, procedures, qualifications (IQ, OQ, PQ), engineering studies (Process Development, confirmation or exploratory studies) and production documentation. Generate high-quality, easily understood technical documents, meeting minutes and presentationsUtilize software to route and control documents for revisions and approval of technical literature.Maintenance of knowledge around procedures and other documentation according to all internal SOP’s and guidelinesAble to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description onitiate and support intra and internal department meetings and projects to achieve team goalsSupport meetings and activities in which project documentation requirements or templates are discussedSupport and contribute in Lean Sigma programs and activities towards team goals Maintain engineering records and documents as requiredAdditional Responsibilities Education Bachelor's Degree Technical Writing Field preferred Work Experience Minimum 5 years experience with Process Engineering required Preferred Knowledge, Skills and Abilities 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 Able to comply with the company’s safety policy at all timesAble to comply with the company’s quality policy at all times. License and Certifications Manufacturing\Lean Six Sigma Certification-IASSC Lean Certification of any level Upon Hire preferred Travel Requirements 10%: Up to 26 business days per yearPhysical Requirements Light-Exerting up to 20lbs/9kg of force frequently, and/or negligible amount of force frequently constantly to move objects.Additional Requirements Has superior analytical, organizational, leadership and technical skillsAbility to assert technical solutions and standardsSelf-motivated, results- and solution-oriented personalityMust have excellent written and verbal skillsExcellent interpersonal skills: good team player and individual contributor as wellInterpret data, read and write, effective communication, decision making, presentation skills