Manufacturing Technical Writer

Rentschler Biopharma • Milford, MA

14h

About The Position

Advancing medicine to save lives. Together. Thanks to many decades of experience and our passion for what we do, we make an essential contribution to the global availability of biopharmaceuticals, especially for patients with rare and serious diseases. Rentschler Biopharma SE is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. We offer customized full-service solutions for bioprocess development and the production of complex biopharmaceuticals. As a German family-owned company with an international footprint and global reach, we combine experts, expertise and years of experience to develop best-in-class solutions – together with our clients. Rentschler Biopharma has approximately 1,400 employees and is headquartered in Laupheim, Germany, with a site in Milford, MA, USA. In 2024, we joined the United Nations Global Compact, underlining our commitment to sustainability. As an independent family-owned company, we live by the motto: Many hands, many minds - ONE TEAM! Open, respectful cooperation characterizes our working environment, where quality awareness, diligence and responsibility are our top priorities. With all the diversity of our talents in the Rentschler team, we pursue one vision together: advancing medicine to save lives. The Manufacturing Technical Writer will be responsible for creating, revising, editing GMP documentation such as manufacturing batch records, SOPs and work instructions.

Requirements

• Bachelor’s Degrees is required
• Biopharmaceutical manufacturing processing in a GMP compliance environment (e.g. Production, Development, Process Engineering, Technical Services or related field)
• 5+ years’ experience in manufacturing, quality & compliance (Clinical, Commercial, Medical Device, MedTech)
• Author of GMP and technical documentation for new and existing processes; Process technical documents, Manufacturing description documents, SOPs, Batch records, Solution records and Training documents
• Experienced with user role in quality documentation systems such as Master control and/or Track wise
• Self-initiator, strong collaborator, proven dot connector, results driven, ability to clearly track work status and communicate to relevant departments, strong capability to resolve challenges to meet deadlines

Responsibilities

• Own the system workflows for creating/revising documentation in Master Control or applicable system
• Revision and management of manufacturing documents such as Batch Records, SOPs and work instructions
• Work with Manufacturing Operations team and Manufacturing Process Optimization team to revise documentation on-time
• Work with Manufacturing Training Manager and Quality Training teams to ensure the documentation is assigned to the correct departments for training as well as with an appropriate amount of training time.
• In addition, work to identify the training types (i.e. read and understand, classroom training, on the job training)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees