Technical Documentalist - Manufacturing Support
This role offers the opportunity to develop and manage technical documentation within a leading Biotechnology company’s state-of-the-art manufacturing facility.
Your primary responsibility will be to own and manage change controls critical to site development and ensure that operational documentation is updated as required by each project.
You will also be responsible for developing, updating and maintaining operations procedures in accordance with site and corporate requirements. This includes serving as a document owner and ensuring that all documentation meets the necessary standards.
In addition to this, you will assist in generating training materials and may provide training on scientific or technical aspects of the process. You will work closely with the manufacturing, inspection and engineering teams to ensure that all documentation is up-to-date and accurate.
The ideal candidate will have a strong background in chemistry, microbiology or engineering, with experience in technical writing and a proven track record of delivering high-quality documentation.
You will also possess excellent communication and presentation skills, with the ability to work independently and deliver results under minimal direction. A bachelor’s degree in a science or engineering discipline is required, along with 3+ years of experience in a biotech, pharma or healthcare organization.
Key responsibilities:
* Develop and manage technical documentation
* Own and manage change controls
* Update operational documentation
* Develop, update and maintain operations procedures
* Serve as a document owner
* Assist in generating training materials
* Provide training on scientific or technical aspects of the process
Requirements
Bachelor's degree in a Science or Engineering discipline
3+ years of experience in Chemistry/Microbiology/Engineering/Validation gained within a biotech, pharma or healthcare organization
Strong Experience in Technical Writing
Good Time Management
Strong Communication and Presentation
We would prefer direct manufacturing or engineering validation experience
Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products an advantage
Strong Project Management and organizational skills, including ability to follow assignments through to completion
Excellent verbal and written communication skills: Strong Technical writing skills for GMP documentation (e.g., investigations, procedures, change controls) and good Presentation skills
Escalate issues professionally and in a timely manner
Ensures compliance within regulatory environment
Demonstrated ability to work independently and deliver right first-time results under minimal direction
Experience participating in and leading cross-functional teams
Experience in managing multiple, competing priorities in a fast-paced environment
This role requires flexibility and adaptability, with a willingness to learn and grow with the company.
A competitive hourly rate is offered, with a minimum 12-month contract.
Onsite expectations: We consider this to be a hybrid role.
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