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Scientific. Clinical. Software Engineering

GMP Facility Maintenance Technical Writer

Edison-New Brunswick Metro Area, NJ

Job Type: Scientific Job Number: JN -062020-26984 Region: Edison-New Brunswick Metro Area

Job Description

The team support all of Summit West therefore they will need to attend CAR T training

1. Work with teams to understand documentation requirements and system operations.

2. Analyze, interpret, revise existing information in the form of equipment manuals, system applications design, statutory/regulatory requirements, and client existing manuals.

3. Creation written schemes and maintenance/calibration/operational process for GMP Facility equipment and system.

4. Write technical work instructions, SOPs, maintenance, and calibration instructions on systems related to facilities equipment related to instruments, controllers, calibrations, or sub-assemblies.

5. Updating documentation and filing system based on system changes and comments from subject matter experts.

6. 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.

7. Validates the accuracy of existing documentation.

8. Provides ad-hoc technical assistance to managers and other members of the GMP Facilities Department.

9. Performs other duties as assigned.

General Requirements:

1. Ability to provide efficient, timely, reliable, and courteous service to customers.

2. Ability to effectively present information.

3. Comfortable presenting in front of groups of people.

4. Strong organization and prioritization skills.

5. The ability to think critically and work through issues with minimal direction or oversight.

Skills/Knowledge Required:

1. Excellent technical writing and verbal communication skills required.

2. If previously employed as a technical writer, you must have experience with maintenance and calibration.

3. Familiarity with techniques of calibration or maintenance practices.

4. 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.

5, Knowledge of FDA guidelines.

6. Ability to work with multiple complex projects and within cross-functional teams.

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