What will you do?
- Create manufacturing documentation for a variety of products and processes, including work Instructions, SOPs, flow charts and other work aids.
- Meet and collaborate with scientists, engineers, quality, product management, and manufacturing to define and establish operational procedures and manuals for operational activities and tasks.
- Write clearly and concisely to meet the needs of the target audience.
- Prepare process flows, specifications, mockups.
- Actively participate as a member of cross-functional new product development teams to ensure compliance with design controls per ISO 13485 and other regulatory requirements.
- Work with minimal supervision and manage time effectively
- Identify and communicate risks to project deadlines in advance
How will you get here?
- Bachelor's Degree in a science related field and 5+ years of technical writing experience, preferably in a pharmaceutical, biotechnology, healthcare, research, or academic environment.
- Experience with ISO 9001, ISO 13485, and/or GMP environments.
- Strong understanding of Design Control and Change Control
- Experience in writing scientific paper is preferred
- Excellent written and verbal communication skills
- Experience with PLM software (Agile, SAP, E1)
- Proficiency in MS Office
Knowledge, Skills, Abilities
- Strong attention to detail and high regards for quality
- Able to write in explanatory and procedural styles for multiple end users
- Skilled at prioritization and multi-tasking in a self-driven, performance/results oriented, fast paced matrixed environment
- Must be highly collaborative: enjoys working in a diverse team and contributes to a positive work environment.