Purpose:An exciting opportunity has opened in the Manufacturing Support team for a Technical Writer. In this role, you will be responsible for owning and managing change controls critical to site development and managing the operational documentation updates as required by each project.Responsibilities:Develop/ Update and maintain Operations procedures in accordance with site and corporate requirements. Serve as a document owner. Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.Liaise with Manufacturing/Inspection/Engineering regarding documentation changes in an effective and timely mannerDevelop protocols for execution in Manufacturing & Inspection in support of change controls, non-conformances & troubleshooting investigations with support from relevant SMEsInvolvement in projects as part of continuous process improvement and/or troubleshootingOwnership and management of change controls as requireIssuance and updates of paper batch records in line with production scheduleLiaise with Quality Assurance to ensure that GMP standards are maintained in line with current OSPartner with Operations lead/appropriate SME to ensure updates are correct and aligned with project deliverables/ timelines.Perform document trending upon project completion to identify keys issues/mistakes in document processing.Support data verification of Operations-owned protocols reports and risk assessmentsSupport the production support team in reducing document turnaround timesUse specified software packages and standard procedures, responsible for compiling and maintaining all relevant documentation including SOPsProvide technical and clerical support to the manufacturing, inspection & engineering teams in the preparation of documentation, collation of data and tracking of SOPEnsure Non-conformance are triage within the established goal and serve as a deviation owner for minor deviations.Own corrective /preventative actions and effectiveness verification.Support execution of C&Q, characterisation, functional testing protocols as required by project. NOTE: This may require flexible working hours.Requirements:Strong Project Management and organizational skills, including the ability to follow assignments through to completionExcellent verbal and written communication skills: Strong Technical writing skills for GMP documentation (e.g., investigations, procedures, change controls) and good Presentation skillsEscalate issues professionally and in a timely mannerEnsures compliance within regulatory environmentDemonstrated ability to work independently and deliver right first-time results under minimal directionExperience participating in and leading cross-functional teamsExperience in managing multiple, competing priorities in a fast-paced environmentBachelor's degree in a Science or Engineering discipline.3+ years of experience in Chemistry/Microbiology/Engineering/Validation gained within a biotech, pharma or health care organizationExperience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products an advantage