Technical Writer - DHF PharmaDevices
Technical Writer - DHF PharmaDevices
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1-3years
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
This is a remote position.
Reports to: Director Quality Engineering
Experience:
- 13 years of experience in development and/or manufacturing in the pharmaceutical biotechnology combination product and/or medical device sectors.
- Experience in Technical Writing within the Pharma Medical Device or BioTech industries is desired.
Projects may include:
- Combination Product Development and Commercialization
- Design Controls (e.g. DHF support)
- Risk Management
- Design Verification and Validation (V&V)
- Human Factors Engineering
- Process Improvement and Troubleshooting
- Technology Transfer and ScaleUp
- Validation (e.g. Shipping Process)
- Regulatory Submission Authorship and Review
- Quality Management Systems (QMS) Support
Additional responsibilities:
- Serve as a technical lead and assist other resources.
- Author documentation to ensure compliance with relevant regulations.
- Support completion of gap assessments.
- Develop policies or SOPs with direction from senior management.
Desired Skills and Aptitude:
- Resourceful and detailoriented.
- Ability to work effectively with remote team members.
- Highly organized and selfdirected.
- Excellent written and oral communication skills.
- Strong customerservice aptitude.
- Ability to motivate teams and thrive in a fastpaced environment.
Requirements
WorkFromHome Setup1. Computer/Devices
- Reliable Desktop or Laptop: Ideally with at least 8GB of RAM a fast processor (e.g. Intel Core i5 or above) and sufficient storage (256GB SSD or higher).
- Backup Device: A tablet or second computer can be handy if the primary device encounters issues.
2. Internet Connection
- HighSpeed Internet: A stable connection with at least 25 Mbps download speed and 5 Mbps upload speed is recommended for video calls file sharing and cloudbased work.
- Backup Internet: A mobile hotspot or second broadband connection in case of outages.
3. Workspace
- Quiet Workspace: A dedicated and quiet space free from distractions for focus.
- Ergonomic Office Chair and Desk: To maintain posture and reduce strain.
4. Backup Power (Optional)
- Power Backup: UPS or a portable power station in case of prolonged power outages.
Benefits
- Work from home
- Competitive Salary
Projects may include: Combination Product Development and Commercialization Design Controls (e.g., DHF support) Risk Management Design Verification and Validation (V&V) Human Factors Engineering Process Improvement and Troubleshooting Technology Transfer and Scale-Up Validation (e.g., Shipping, Process) Regulatory Submission Authorship and Review Quality Management Systems (QMS) Support Additional responsibilities: Serve as a technical lead and assist other resources. Author documentation to ensure compliance with relevant regulations. Support completion of gap assessments. Develop policies or SOPs with direction from senior management. Desired Skills and Aptitude: Resourceful and detail-oriented. Ability to work effectively with remote team members. Highly organized and self-directed. Excellent written and oral communication skills. Strong customer-service aptitude. Ability to motivate teams and thrive in a fast-paced environment.
Employment Type
Full Time
