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 requirements Clear, error-free and accurate standard documentation Develop 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 presentations Utilize 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 guidelines Able 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 goals Support meetings and activities in which project documentation requirements or templates are discussed Support and contribute in Lean Sigma programs and activities towards team goals Maintain engineering records and documents as required Additional 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 times Able 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 year Physical 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 skills Ability to assert technical solutions and standards Self-motivated, results- and solution-oriented personality Must have excellent written and verbal skills Excellent interpersonal skills: good team player and individual contributor as well Interpret data, read and write, effective communication, decision making, presentation skills West 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.