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Sean McCarthy
Life Science

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Senior Technical Operations Engineer (Partially Remote)

Reference:SMC74685 Location: Cork
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Process Engineer

We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

The Technical Operations Engineer is a member of the Technical Operations (TO) Team and a key contributor to process improvement initiatives. In addition, they should have a keen aptitude for implementing and maintaining standards and driving efficiency within the business while supporting introduction and validation of new and existing products. The Technical Operations Engineer provides technical support for processes by providing facilitation / technical expertise.

Key Responsibilities:
• Manage / execute the validation and cleaning program for new and existing products
• Issue / review validation plan, protocols and reports
• Be the site TO representative in Cluster/NPI project teams as process / validation SME
• Strong analytical and Problem Solving skills
• Lead complex investigations on the site by providing 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 requirements.
• Conduct and/or participate in problem solving efforts by analysis and correction of both process and equipment problems to maintain or improve existing site operations.
• Represent Technical Operations in engineering projects and coordinate small engineering projects.
• Support the introduction of new processes by coordinating and executing the preparation activities.
• Assist in process and equipment design to support new products and the legacy product portfolio.
• Execute cost reduction and efficiency improvement projects using Process or Design Excellence techniques. Utilizes appropriate risk management tools such as FMEA, HAZOP, LOPA and business risk evaluations.
• Conduct training for operations and maintenance personnel.
• Maintain knowledge of cGMPs, process safety practices and environmental standards.
Additional position requirements

Education & Experience

• 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.

If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or [email protected] for further information.