Bristol Myers Squibb Technical Documentation Writer in Devens, Massachusetts
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
The selected candidate will author Standard Operating Procedures (SOP) and Master Batch Records (MBR) for the manufacture of therapeutic proteins in accordance with Current Good Manufacturing Practices (cGMP’s). Responsibilities include authoring MBRs for batch data collection using Facility Fit Report (FFR) as source documents for new campaigns, revising standard operating procedures and managing the flow of documents through an electronic document management system. The incumbent will works with Manufacturing Support, Quality and area management to ensure timely delivery of documents prior to the start of a product campaign.
Expertise manipulating templates, tables and graphics.
Ability to manage simultaneous creation of multiple MBRs. Delivery of documents by due dates.
Strong knowledge of either upstream or downstream unit operation is essential.
Ability to work independently and handle multiple priorities in a dynamic cross-functional team based environment.
Utilization of good communication skills to effectively collaborate with co-workers at all levels of the organization.
Works on routine manufacturing assignments as well as assignments that are complex in nature where action and a high degree of initiative are required to resolve problems and make recommendations.
Previous work experience where attention to detail and personal accountability were critical to success.
Strong aptitude with Microsoft office suite with ability to interpret and understand the technical source document.
Knowledge and Skill:
Knowledge of science generally obtained through Associates or 4-Year degree in engineering, biochemistry or related discipline is preferred.
A minimum of 5+ years process operations experience in a biotechnology manufacturing facility subject to GMP regulations with at least one year experience with technical writing.
Practical knowledge of regulations such as GMP and company Standard Operating Procedures (SOP).
Prior evidence of successful participation on work teams where combined contribution, collaboration, and results were expected
Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web based applications.
Previous work experience where attention to detail and personal accountability were critical to success
Demonstrates good interpersonal skills, is attentive and approachable.
Maintains a professional and productive relationship with area management and co-workers.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Company: Bristol Myers Squibb
Req Number: R1532712-en-us
Updated: 2020-12-04 00:56:10.706 UTC
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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