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Sean McCarthy
Life Science

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Details

Technical Operations Specialist


Reference:SMC11701 Location: Cork
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Technical Support

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.

Duties

• Conduct Technical Operations activities in compliance with US and EU regulations and EHS&S requirements.
• Technically assess alternatives and changes to Single-Use assemblies and components (eg. SUMs/SUBs/filters) proposed by vendors.
• Participate in cross-functional risk assessment of alternatives proposed to mitigate stocked out materials.
• Assess change controls and implement activities in accordance with site procedures.
• Perform Extractable and Leachable (E&L) Risk assessments.
• Liaise with Single-Use polymeric vendors.
• Co-ordinate validation activities supporting qualification of alternative Single-Use components eg. filter validation testing.
• Attend identified training, required to fulfill the role of a Technical Operations Specialist.
 
Education & Experience

• Bachelors Degree in a scientific/technical discipline required
• Experience in Single-Use Disposable Material Qualification.
• Experience with Change Control and Trackwise.
• Knowledge of Upstream and Downstream large molecule drug substance processes.

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