Manufacturing Technical Writer (6+ Month Contract)

About the role

Rentschler Biopharma SE is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects, offering customized full-service solutions for bioprocess development and production of complex biopharmaceuticals. As a German family-owned company with approximately 1,400 employees headquartered in Laupheim, Germany, and a site in Milford, MA, USA, the company joined the United Nations Global Compact in 2024, emphasizing sustainability. The Manufacturing Technical Writer will be responsible for creating, revising, and editing GMP documentation such as manufacturing batch records, SOPs, and work instructions. Working conditions include lab and office environments, with PPE required as needed.

Responsibilities

• Generate, revise, and manage Upstream Master Production Records (MPRs) and associated GMP documentation, including batch records, SOPs, and work instructions, ensuring accuracy, compliance, and on-time implementation.
• Serve as the documentation lead for upstream manufacturing processes, utilizing knowledge of cell culture operations, subcultivation, perfusion, and single-use bioreactor systems to develop and maintain manufacturing instructions.
• Own document workflows within quality systems, including document creation, routing, review, approval, revision control, and implementation activities.
• Partner with Manufacturing Operations, MSAT, Process Engineering, Quality, and Training teams to ensure documentation is completed on schedule, assigned to the appropriate departments, and supported by the appropriate training strategy.

Qualifications

• Bachelor’s Degree 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

Skills

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.

Benefits

• Annual discretionary bonus program
• Medical insurance
• Generous 401K program
• Other benefits supporting personal and professional wellness

Pay

Base Pay Range: $38/hr - $50/hr