Job Description
", "
We are seeking a skilled professional to support our Manufacturing Support team as a Technical Writer.
", "
In this role, you will be responsible for managing and maintaining critical change controls that drive site development, as well as leading operational documentation updates in support of various projects.
", "
This position is primarily site-based, offering the chance to work closely with cross-functional teams to ensure all documentation is accurate, compliant, and aligned with regulatory standards.
", "
* Develop, update, and maintain operations procedures and training materials; serve as document owner.
* Coordinate documentation changes with Manufacturing, Inspection, and Engineering teams promptly.
* Create protocols for manufacturing and inspection to support change controls, investigations, and troubleshooting.
* Participate in projects for process improvement and troubleshooting.
* Own and manage change controls and paper batch records aligned with production schedules.
* Collaborate with Quality Assurance to ensure GMP compliance.
* Work with Operations leads and SMEs to ensure documentation aligns with project timelines.
* Analyze document trends post-project to identify issues.
* Support data verification for protocols, reports, and risk assessments.
* Assist production support team to improve document turnaround times.
* Use software to compile and maintain SOPs and related documents.
* Provide technical and clerical support for documentation and SOP tracking.
* Manage minor deviations, non-conformance triage, and corrective/preventative actions.
* Support execution of commissioning, qualification, and testing protocols, including flexible hours if needed.
", "
Required Experience
", "
A Bachelor's degree in a Science or Engineering discipline is required. Additionally, 3+ years of experience in Chemistry/Microbiology/Engineering/Validation gained within a biotech, pharma or medical device company is necessary.
", "
Regulatory compliance experience in cGMP manufacturing and testing of pharmaceutical products is an advantage.