Senior GMP Manufacturing Technical Writer

Rentschler Biopharma SE; Milford (MA); On-site; USD 52,000 - 69,000; Full time

Job summary

Rentschler Biopharma SE in Milford, MA, seeks a Manufacturing Technical Writer to generate, revise and manage GMP documentation for upstream production, including batch records, SOPs and work instructions.

You will own document workflows and collaborate with Manufacturing Operations, MSAT, Process Engineering, Quality and Training to ensure documentation is completed on schedule and training is aligned in a fast-paced biopharma environment.

Qualifications

• Bachelor's degree in Life Sciences or related field required.
• Experience authoring GMP and technical documents for new and existing processes.
• Ability to collaborate across Manufacturing Operations, Quality, and Training teams.

Responsibilities

• Create, revise, and manage Upstream Master Production Records (MPRs) and GMP documents.
• Develop and maintain manufacturing instructions for upstream cell culture operations and single-use bioreactor systems.
• Own document workflows in quality systems with routing, approval, revision control, and training alignment.
• Partner with Manufacturing Operations, MSAT, Process Engineering, Quality, and Training to ensure on-time completion.

Skills

Bachelor's degree

GMP documentation experience

Cross-functional collaboration

Documentation management

Education

Bachelor's degree in Life Sciences / Biopharma

Tools

MasterControl

TrackWise

Job description

Rentschler Biopharma SE in Milford, MA, seeks a Manufacturing Technical Writer to generate, revise and manage GMP documentation for upstream production, including batch records, SOPs and work instructions.

You will own document workflows and collaborate with Manufacturing Operations, MSAT, Process Engineering, Quality and Training to ensure documentation is completed on schedule and training is aligned in a fast-paced biopharma environment.