Our client, a leading pharmaceutical company, located in Cork is recruiting for a Senior Operations Engineer. This is a contracting role and the position will be a key contributor to process improvement initiatives on the site.
Technical Operations Engineer is a member of the Technical Operations (TO) Team with the dedicated focus on Continued Process Verification, Process Validation, process Improvements, leading complex cross functional investigations and standards and new technology deployment
- Manage / execute the validation program related to LCM for existing products
- Issue / review validation plan, protocols and reports
- Be the site TO representative in LCM/NPI project teams as process / validation SME
- As required coordination of LCM projects on site, under responsibility of global TO organization
- Own / participate in the CPV program by issuing plans, protocols and reports and oversee execution.
- Lead complex investigations on the site by providing facilitation / technical expertise
- Provides process / technology input to SOP’s, Master Batch Records and change controls
- Partner with Engineering & Maintenance and contribute to equipment changes / introduction projects on the site
- Lead / support process improvement projects, including new technology / analytics introduction (e.g. MVA, PAT)
- Contribute to Standardization initiatives for Technical Operations
- Technical support / direct participation in partnership with Quality / Operations on any regulatory audits and inspection
Education, Experience and Skills
- Honours degree in Engineering or Science, with minimum 5 years’ experience in a pharmaceutical environment
- Desirable candidate would have Master Degree or Equivalent with 5 – 8 years’ experience in a pharmaceutical environment.
- Self-driven and keeps up to date with regulatory, technical developments within the industry.
- Focus on patients and customers at all times.
- Strong analytical and Problem Solving skills and project management (FPX or other)
- Excellent communication, written and oral with acute attention to detail
- Excellent team player with strong customer focus
For further information on this Engineer role in Cork please contact Deirdre Finnerty on 086 3073779/ firstname.lastname@example.org
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