Senior MSAT Engineer - Pharmaceuticals - Dundalk

Do you want to work for one of the world’s fastest growing pharmaceutical companies?

With heavy investment year on year, this company are expanding at a rapid pace. They are becoming a household name within the Pharmaceutical and Bio-Pharmaceutical sectors. With manufacturing sites around the world, they regularly win awards to confirm their status as a market leader. This facility in Massachusetts is a trademark facility which is bringing great attention to the company in the US.

Currently they are looking for a Senior MSAT Engineer to join their team.

Responsibilities

• Develop, generate, and execute TT protocols and reports independently. Review and approve documents prepared by other MSAT colleagues.
• Independently lead, the company Vaccines process performance qualification (PPQ) and relative studies with DP manufacturing. Support Manufacturing to perform any scale-up or process adaptations during PPQ.
• Collaborate with different functional groups (e.g. Supply Chain, Production Unit, Quality Control, HSE, other sites.) to complete PPQ with no delay on project schedule.
• Regularly liaise with customer and represent MSAT department as required, acting at key strategy meetings to inform and decide correct path through TT, with respect to current regulatory best practices and requirements, cost, and schedule.
• Factory floor support for manufacturing during critical stage operation execution during PPQ batches.
• Leads new product introductions and lifecycle changes into a vial processing plant, from a Process Development perspective and then acts as process and technical SME during CV stage.
• Troubleshoots issues with drug product processing technologies and equipment, in the scale up and commercialisation, during NPI.
• Leads and collaborates on cross functional investigation teams, utilising root cause analysis: 5-
  
  

Requirements

• BS/MS with major in Biology, Chemistry or Pharmaceutical Engineering or related Science or Engineering major or person with equivalent experience.
• Have prior development or commercial experience in one or more of the following areas: Formulation, Filling and/or Lyophilization. Vaccine experience desirable.
• Have prior experience in the generation of validation protocols, analysis of validation data, and technical writing of validation reports.
• Have process development or process validation experience, having worked on NPI and TT projects previously.
• Have the experience to perform, lead, and close variation/deviation investigation for development or commercial product.
• Minimum 6 years working in a cGMP pharmaceutical, biological, or vaccine clinical or commercial production facility within a technical support role.
• Have knowledge and understanding of biopharmaceutical cGMP quality systems and operations.
  
  

If this role is of interest to you, please apply now!

The candidate must have the rights to work in the location stated in the job advert.

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