Applications are invited for the temporary position (12 month contract) of Process Engineer I/II within the Process Development Group. Reporting to the Process Development Associate Director or designee, the successful candidate will be responsible for supporting assigned Process Development projects.
- Provide technical support/execution for new and existing technology based process development programs
- Prepare and execute experimental programs involving investigational studies to provide process/analytical data for process selection and identification of critical process parameters.
- Analyse the process and analytical data generated by these programs and report on same.
- Develop and execute process development activities focused on study of critical parameters to ensure that process conditions, at all scales, are consistent and not at “edge of failure”.
- Develop/execute scale-up/optimisation studies as part of process modelling.
- Analyse and provide resolution of technical issues.
- Generate documentation to support product design and implementation activities within a cGMP environment.
- Support FDA pre-approval and post-approval inspections for development and processing operations.
- Present, where appropriate, technical data to internal / external groups including audit groups (IMB & FDA).
- Ensure all Company and departmental policies and procedures are adhered to
- Minimum third level qualification in Science, Chemical Engineering or Industrial Pharmacy (Level 7).
- Process Engineer I - up to 3 years pharmaceutical or related experience or Process Engineer II – minimum 4 years pharmaceutical or related experience.
- Experience of process development/engineering, formulation and related commercial scale-up/manufacturing in the pharmaceutical industry an advantage.
- Strong technical and project management skills.
- Demonstrated ability in generating technical options to resolve problems, prioritising solutions, selecting optimal solutions and implementing decisions.
- Experience in statistical analysis an advantage
- Adaptable to changing priorities.
- Excellent verbal and written communication skills.
- Proven track record in current role is essential.
Alkermes provides equal opportunities to all employees and applicants for employment