Fixed Term Process Engineer I/II

Alkermes, Inc. - Athlone, County Westmeath (30+ days ago)

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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.

Key Responsibilities
  • 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