Technical Documentation Writer

Marlborough, MA
Job ID:

We are looking for a Technical Document Writer to work with our expert Biomanufacturing team. Do you have a passion for Biotechnology? Then we would love to hear from you.

What you will do:

·        Responsible for writing, reviewing, and driving production and quality documentation to approval.

·        Responsible for producing high-quality cGMP documentation that contributes to the overall success of our project goals.

·        Originate, revise, and maintain Standard Operating Procedures (SOPs), Production Batch Records (PBRs) and Solution Preparation Records.

·        Originate, track and close Quality documents (CAPAs, CRs, TCRs, Deviations).

·        Compile and draft procedural documentation using standard electronic publishing tools.

·        Create and maintain templates for cGMP documents.

·        Collaborate with individuals from various internal functional areas to generate and review new equipment, processing, set-up, and operational documents within agreed upon timelines.

·        Interview subject matter experts to obtain details to accurately capture content material.

·        Demonstrate effective written and verbal communication skills.

·        Monitor the flow of production documents and adjust workload and resources in an appropriate, organized, and efficient manner.

·        Work with cross-functional teams on the implementation of process improvement initiatives to increase quality in cGMP documentation.

·        Demonstrate an ability to multi-task and manage multiple projects independently.

Qualifications / Who you are:

·        3+ years of previous technical writing experience in a cGMP pharmaceutical environment.

·        Experience in manufacturing under cGMP guidelines and possess a strong knowledge of cGMP requirements.

·        Prior experience working in a biotech/pharmaceutical company.

·        Exceptional written/verbal communication, listening, organizational, interpersonal, research, investigative, and problem-solving skills.

·        Proven ability to communicate complex ideas in a clear, concise manner.

·        Working knowledge of MS Office Suite and an Electronic Document Management System (EDMS).

·        Experience with Document Proficiency in Microsoft Office Products. Demonstrates ability to communicate with co-workers and leadership.

Preferred Qualifications

·        Associates degree in a scientific discipline or equivalent experience.

·        Cell Culture experience.

·        Protein Purification experience.

·        Biological Technical Transfer experience.

·        Prior experience working in a cGMP biopharmaceutical manufacturing environment.

·        Experience with single use biomanufacturing systems

Who we are?

Whatever your role, we bring purpose and challenge into our everyday work. If you are driven to make the world a better place thanks to science and medicine, you will feel right at home here. If you are flexible, curious, and relentless, you’ll belong. If you are excited about a global culture, this can be the place to further your career.