SimoTech require a Technical Writer for a Pharmaceutical project based in Dublin. Candidates must have at least 2-3 years’ experience in in the biotechnology, pharmaceutical or life sciences industries.
- Develop, review and update Manufacturing, Inspection and Engineering Standard Operating Procedures.
- Responsible for the timely development of protocols for execution in Manufacturing & Inspection in support of change controls, nonconformances & troubleshooting investigations with support from relevant SMEs to be delivered against tight deadlines.
- Work with Manufacturing/Inspection/Engineering to ensure documentation changes are carried out in an effective and timely manner.
- Will be involved in numerous projects as part of continuous process improvement and / or troubleshooting.
- Take ownership of change controls for Manufacturing/Inspection/Engineering issuance and updates of paper batch records in line with production schedule.
- Liaise with Quality Assurance to ensure that GMP standards are maintained in line with current OS.Support in ensuring document turnaround times are kept to a minimum.
- Provide technical and clerical support to the Manufacturing, Inspection & Engineering teams in the preparation of documentation, collation of data and tracking of SOPs.
- The technical writer will take ownership of all relevant Level 1 non-conformances.
- Update design documents and Business builds.
- Educated to degree level or equivalent.
- Significant experience in Chemistry/Microbiology/Engineering/Validation gained within a biotech, pharma or health care organisation will be beneficial to the candidate.
- The ideal candidate will have experience in drafting various equipment protocols & test cases.
- Significant technical writer experience is necessary and a full understanding of how to author a document in line with validation requirements is also required.
- Any prior experience in a Fill / Finish facility is ideal, or experience in other Life Sciences industries will suffice.
- The equipment involved in relevant projects includes Formulation / Fillers / Freeze Dryer / Inspection Systems / Packaging Lines. Any previous experience of some or all of these would be beneficial.
- Knowledge of firewall rules and industrial communication is beneficial.
- Role provides a high degree of autonomy to allow the successful candidate to reach their full potential.
- Develop new skills and enhance technical ability by working with innovative technologies in a multi-disciplined environment.
- Opportunity to work with large corporate clients on exciting projects.
- Flexible working hours and location.
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