Rob Walker is recruiting for a Senior Process Engineer to join a pharmaceutical company based near Dublin, Ireland. This company manufactures a wide range of pharmaceutical products for the human health market and this is a fantastic opportunity to join them on a 12 month contract.
This role will require the candidate to lead inspection activities for transfer of vial and syringe products and the on-going support to Manufacturing. The candidate will provide technical support to the Inspection areas at ADL as well as being part of the global Process Development organization.
This contract is offering an hourly pay rate of up to €55phr (Ltd company contractor) depending on experience.
Further responsibilities will include:
• Leading Inspection NPI activities from a Process Development perspective and serving as the Process Development Inspection SME.
• Acting as an inspection technical expert to provide solutions when troubleshooting inspection issues through the NPI or post-NPI phases.
• Interfacing with manufacturing as well as all support functions to provide robust and coordinated support to manufacturing.
• Conducting risk assessment for inspection operations and propose / implement appropriate CAPA.
• Development of Validation Plans, IOQs and PQs
• Ensuring all aspects of activity within any given Process Validation adheres to required policies and procedures, including safety and training.
• Ensuring that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards
• Liaising with Operations, Engineering and external vendors regarding new or amended equipment which would impact the Validated Process.
As a Senior Process Engineer, you will have the following Qualifications, Skills and Experience:
• Relevant qualification in Science, Engineering or a relevant Quality discipline with significant' experience in a similar role
• Knowledge of cGMPs, other worldwide regulatory requirements, inspection processes and vision systems
• Knowledge of Knapp studies, inspection equipment qualifications, manual inspection qualifications
• Experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as Process Characterization, Tech Transfer (to commercial DP sites) or Validation.
• Strong skills in applying fundamental engineering and scientific principles to the design and implementation of Inspection processes
• Project management skills including the ability to manage multiple projects and evaluate project resource requirements.
Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Engineers is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference ENG39733 in all correspondence.
You MUST be eligible to work in Munster. Learn more
- Agency: CK Group (Science, Clinical, Engineers and IT Recruitment)
- Posted: 31st July 2017
- Expires: 1st September 2017
- Reference: ENG39733