Manufacturing Technical Writer (6+ Month Contract)

Socket.dev; Milford (MA); On-site; USD 79,000 - 104,000; Full time

Benefits offered by this job

Medical insurance

401K plan

Annual bonus program

Job summary

Rentschler Biopharma SE, with a site in Milford, MA, seeks a Manufacturing Technical Writer to create and revise GMP manufacturing documentation across upstream processes. You will own MPRs, SOPs and work instructions, ensuring accuracy and on-time implementation in a fast-paced biopharma setting.

Ideal candidates bring 5+ years in GMP documentation, familiarity with MasterControl or TrackWise, and strong cross-functional collaboration skills to align with Quality, MSAT, Process Engineering and

Qualifications

• Bachelor's degree required in a related field.
• 5+ years' experience in manufacturing, quality & compliance in GMP environments.
• Experience authoring GMP and technical documentation for processes.

Responsibilities

• Generate, revise, and manage Upstream Master Production Records and GMP documentation.
• Serve as documentation lead for upstream manufacturing processes and training strategies.
• Own document workflows within quality systems and coordinate cross-functional teams.
• Collaborate with Manufacturing Ops, MSAT, Process Engineering, Quality and Training.

Skills

GMP documentation experience

Quality systems knowledge

Cross-functional collaboration

Education

Bachelor's degree

Tools

MasterControl

TrackWise

Job description

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 hasapproximately1,400 employees and is headquartered in Laupheim, Germany,with asite 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.

Duties and 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 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

Working Conditions

• Lab environment
• Office environment

Physical Requirements

• PPE as required

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Base Pay Range
$38/hr - $50/hr
Disclosure Statement
Rentschler Biopharma, Inc is committed to fair and equitable compensation practices. The base pay range listed for this position is the anticipated annual base salary range the organization reasonably, and in good faith, expects to pay for this position at this time. Actual compensation is determined based on several factors that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other application factors permissible by law. The annual base salary is just one component of our Total Rewards package, which also includes our annual discretionary bonus program, medical insurance, our generous 401K program, plus a host of other benefits to aligned to support our employees’ personal and professional wellness. The salary pay range is subject to change and may be modified at any time.