Manufacturing Technical Writer (6+ Month Contract)

Rentschler Biopharma Inc.; Milford (CT); On-site; USD 52,000 - 69,000; Full time

Job summary

Rentschler Biopharma Inc. in Milford, MA seeks a Manufacturing Technical Writer to create, revise and manage GMP documentation for upstream manufacturing processes.

You will own MPRs, batch records, SOPs and work instructions to ensure accuracy and on-time implementation. You will lead documentation workflows within quality systems and partner with Manufacturing Operations, MSAT, Process Engineering, Quality, and Training teams to keep documentation current and properly trained for production

Qualifications

• 5+ years of experience in manufacturing, quality & compliance.
• Author of GMP and technical documentation for new and existing processes (SOPs, batch records, training docs).
• Experience with quality documentation systems (MasterControl, TrackWise).
• Self-initiator, strong collaborator, able to track status and meet deadlines.

Responsibilities

• Generate, revise, and manage Upstream Master Production Records (MPRs) and GMP docs with accuracy and on-time implementation.
• Serve as the documentation lead for upstream manufacturing processes, including cell culture operations and bioreactor systems.
• Own document workflows in quality systems: creation, routing, review, approval, revision control, implementation.

Skills

5+ years in manufacturing quality &amp

Author of GMP/technical docs

Quality documentation systems

Self-starter, collaborative

Education

Bachelor's degree in a relevant field

Biopharmaceutical GMP experience

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 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.

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

Base Pay Range

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. Rentschler Biopharma is a 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. What unites us at Rentschler Biopharma, is the passion for what we do. We empower our clients to help patients with serious or rare diseases. 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, we pursue one vision together: advancing medicine to save lives.