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Process Engineering Technical Writer
3 months ago
You Matter to Cambrex.
Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,000 professionals servicing global clients. Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.
Your Work Matters.
At Cambrex, we strive to build a culture where all colleagues have the opportunity to:
engage in work that matters to our customers and the patients they serve learn new skills and enjoy new experiences in an engaging and safe environment strengthen connections with coworkers and the community
We’re committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more
Your Future Matters.
Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today
Job Overview
The PE Technical Writer will be responsible for consistently generating high quality technical documents, such as batch records, deviations, protocols, and reports based on data collected by other members of the Process Engineering team that meet the needs of other departments, clients, and regulators. Compliance with SOPs, cGMP, and other regulatory guidelines is required to perform most job tasks.
Responsibilities
Drafting and revising controlled documents such as batch records, cleaning records, process validation protocols and reports, WINS and SOPs, campaign reports, investigation/deviation reports and other documents needed to support Operations while following established guidelines for correctness, completeness, clarity, and format. Coordinate the approvals of these documents through the use of software such as MasterControl and TrackWise. Compile and present data from multiple sources such as executed batch records and executed analytical records. Maintain open communication with members of Process Engineering, Operations, and QA to ensure timely delivery of high quality documents to support evolving business needs. Continuously improve documentation systems to increase efficiency and compliance with cGMP and/or other regulatory requirements.
Qualifications/Skills
Advanced technical writing skills and the ability to communicate effectively with peers, department management, and cross-functional coworkers. Fluent in written English. Familiarity with compliance requirements within cGMP with an emphasis on procedures, process validations, and reporting requirements preferred. Demonstrated excellence in advanced word processing using Microsoft Word and other Microsoft Office products. Demonstrated computer literacy, including spreadsheets, structural drawings, databases, and communication packages preferably in a Windows environment. Ability to work in a highly independent and self-directed work environment.
Education, Experience & Licensing Requirements
Associate degree in a technical discipline or closely related field is required. Minimum of 2 or more years of experience in a cGMP regulated manufacturing environment highly preferred.
Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration.
All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.
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