What are the responsibilities and job description for the Technical Writer position at Fusion Life Sciences Technologies LLC?
Key Responsibilities:
- Design and develop project control templates, including but not limited to:
- Section Group Templates
- Document Templates
- Object Templates
- Establish stage-gated project management frameworks utilizing project documentation, plans, schedules, and procedures.
- Lead system configuration enhancements and support the implementation of process improvements within the Kneat platform.
- Collaborate closely with the CQV (Commissioning, Qualification, and Validation) team to:
- Develop and document test cases
- Assist in protocol drafting (IQ/OQ/PQ)
- Define and manage workspace structures
- Oversee document lifecycle and approval processes within Kneat
- Provide technical support and training, including:
- End-user training and onboarding
- Hyper-care support during implementation phases
- Ongoing template administration and configuration updates
- Monitor and report on system performance and KPIs, ensuring continuous improvement and regulatory compliance.
Candidate Requirements:
- Proven experience with Kneat Gx platform in a GMP/GxP-regulated environment.
- Strong technical writing and documentation skills.
- Deep understanding of validation lifecycle processes and regulatory standards (e.g., GAMP 5, 21 CFR Part 11).
- Ability to work cross-functionally in a fast-paced, collaborative setting.
