Applications are invited for the fixed term contract (12 months) of a Lead Engineer II reporting directly to the Validation Manager. While the role will be focused on Process Validation, the candidate should be an SME in other areas of Validation. The successful applicant will be play a lead role within Alkermes, representing Validation.
- SME in Process Validation.
- Development and execution of Validation related documents throughout the system lifecycle.
- Understand the science and areas of technical knowledge that underpin area of focus and must be able to apply this knowledge in the development of validation approach and in the presentation, documentation/recording & review of outcome.
- Understand best industry practice, current developments and opportunities arising for Alkermes.
- The holder of the position will be required to contribute effectively in the following areas - change control and investigations.
- Determine levels of importance or risk to be assigned to elements under review – using scientific rationale to justify scale of effort.
- Represent the validation group in projects and other cross functional teams.
- Third level qualification in a Science, Engineering or other related field (to level 8) with 8 years relevant experience.
- Subject matter expert in at least three main areas of validation (Process/Cleaning/ Equipment /Utilities /Facilities/Computer Systems). An individual at this level is considered to be a technical expert in the field of validation.
- Must be (or quickly become) familiar with Regulatory requirements and guidance applicable in area(s) of deployment.
- Areas of expertise include formulation, chemistry and statistics.
- Lead and structure scientific debate and assessment with peers from other technical areas to develop scientific understanding
- Excellent written and verbal communications, including technical writing. Microsoft Office Software, with MS Project.
- Experience in the biotechnology and/or pharmaceutical industries is desirable.
- Practical experience with quality risk management and risk based validation approaches.
- Thorough understanding of industry standards and best practices for Validation.