Technical Writer - Manufacturing Support
Job Summary
An exciting opportunity has opened within our Manufacturing Support team for a Technical Writer. In this role, you will be responsible for owning and managing critical change controls driving site development, alongside updating operational documentation to support ongoing project deliverables.
Location: This is a primarily on-site position based at our state-of-the-art pharmaceutical manufacturing facility.
Primary Responsibilities
Documentation & Process Management
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SOP Ownership: Develop, update, and maintain Standard Operating Procedures (SOPs) in strict alignment with site and corporate requirements.
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Batch Records: Issue and update paper batch records in close alignment with the active production schedule.
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Technical Writing: Compile, track, and maintain all relevant GMP documentation, technical procedures, and software-specific packages.
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Training Support: Assist in the generation of training materials and provide guidance on the scientific or technical aspects of manufacturing processes.
Quality, Compliance & Cross-Functional Collaboration
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Change Controls & Investigations: Own and manage change controls, non-conformances, and troubleshooting investigations. Develop execution protocols with support from subject matter experts (SMEs).
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Cross-Functional Liaison: Partner closely with Manufacturing, Inspection, Engineering, and Quality Assurance teams to ensure timely documentation updates and unwavering adherence to cGMP standards.
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Deviation Management: Triage non-conformances within established timelines, acting as a deviation owner for minor issues, and managing corrective/preventive actions (CAPA) through to verification.
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Data Verification: Support data verification for operations-owned protocols, risk assessments, and reports, performing document trending post-project to optimize turnaround times.
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Testing Support: Assist in the execution of Commissioning & Qualification (C&Q), characterization, and functional testing protocols as required by the project (Note: This may occasionally require flexible working hours).
Knowledge & Skills
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Technical Communication: Exceptional verbal and written communication skills, with a proven track record of drafting high-quality GMP documentation (investigations, procedures, change controls).
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Project Management: Strong organizational skills with the ability to manage multiple competing priorities in a fast-paced environment and drive tasks to completion.
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Autonomy & Accuracy: Demonstrated ability to work independently, deliver "right-first-time" results under minimal direction, and professionally escalate issues when necessary.
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Leadership & Collaboration: Experience participating in and leading cross-functional teams while ensuring absolute regulatory compliance.
Education & Experience
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Education: Bachelor's degree in a relevant Science or Engineering discipline.
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Experience: 3+ years of experience within a biotechnology, pharmaceutical, or healthcare organization-specifically within Chemistry, Microbiology, Engineering, or Validation.
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Compliance: Direct experience with regulatory compliance in a cGMP manufacturing and pharmaceutical testing environment is highly advantageous.
