Technical WriterAn amazing opportunity has arisen for a Technical Writer in a manufacturing support team on a hybrid basis. This is a hybrid position and you will be responsible for owning and managing change controls critical to the site development.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 requiredIssuance 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 SOPsEnsure 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.Preferred:Bachelor'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 advantageBerkley Life Science & Engineering is a specialist consultancy recruiting Life Science & Engineering professionals for organisations throughout Ireland; for more information go to www.berkley-If you would like to discuss this vacancy further or to discuss your career options in confidence, please contact David O'Connell on or send your CV to-