Location: Summit, New Jersey, United States
Job Type: Contract
Responsibilities will include, but are not limited to the following:
- Work with teams to understand documentation requirements and system operations.
- Analyze, interpret, revise existing information in the form of equipment manuals, system applications design, statutory/regulatory requirements, and client existing manuals.
- Creation written schemes and maintenance/calibration/operational process for GMP Facility equipment and system.
- Write technical work instructions, SOPs, maintenance, and calibration instructions on systems related to facilities equipment related to instruments, controllers, calibrations, or sub-assemblies.
- Updating documentation and filing system based on system changes and comments from subject matter experts.
- Conducts research and interviews technical and business personnel and reads existing journals/documentation/user manuals to become familiar with product technologies and calibration/maintenance methods.
- Validates the accuracy of existing documentation.
- Provides ad-hoc technical assistance to managers and other members of the GMP Facilities Department.
- Performs other duties as assigned.
- Ability to provide efficient, timely, reliable, and courteous service to customers.
- Ability to effectively present information.
- Comfortable presenting in front of groups of people.
- Strong organization and prioritization skills.
- The ability to think critically and work through issues with minimal direction or oversight.
- Excellent technical writing and verbal communication skills required.
- If previously employed as a technical writer, you must have experience with maintenance and calibration.
- Familiarity with techniques of calibration or maintenance practices.
- Proficiency in the use of Microsoft Word, Excel, data graphics software, Adobe Acrobat, and web-based browser software such as electronic document authoring, reviewing, and approval process.
- Knowledge of FDA guidelines.
- Ability to work with multiple complex projects and within cross-functional teams.
Sthree US is acting as an Employment Business in relation to this vacancy.