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Senior Manufacturing Engineer

Reference ID : 541MQ
Category :
  • Pharma / Biotech
Date Posted : Feb 5, 2019
Job Location
  • Leinster
- Dublin
Experience : Minimum 8~10 Years experience
Salary : Negotiable - DOE
Employment Type
Michael McQuade
Contact Number : 0860435195
We have a position for a Senior Manufacturing Engineer at our client’s Biopharma facility in Dublin. This a senior role of minimum 12 months duration.

Principal Responsibilities

Senior Manufacturing Engineer

  • Develop, review and update production Standard Operating Procedures. 
  • Develop, review and update master/generic batch records, bills of materials etc. 
  • Develop, review and update Product Quality Risk Assessments. 
  • Function as the Manufacturing point of contact on New Product Introduction (NPI) Projects.
  • Partner with key functional groups to drive strategy definition for risk assessments, characterization, validation, regulatory, and filing milestones. 
  • Lead Product Team meetings. 
  • Ensure compliance with project milestones such as conformance batches manufacturing, regulatory submissions, and product launches. 
  • Hold people to account for delivery and behaviours within Product team. 
  • Function as the site interface between the Product Delivery Teams (PDT’s), and site Senior Management. 
  • Author, Reviewing and Approving new training materials. 
  • Develop, review and update Protocols for manufacturing activities. 
  • Documentation and approval of protocol deviations for manufacturing activities. 
  • Perform Job Hazard Assessments and Change Control Assessments to determine impact to Manufacturing. 
  • Liaise with Quality Assurance to ensure that GMP standards are maintained in line with current SOP’s, batch documentation and licences. 
  • Liaise with Process Development regarding documentation changes in an effective and timely manner. 
  • Use specified software packages and standard procedures, responsible for compiling and maintaining all relevant documentation including batch documentation, bills of materials and SOP’s for submission to the Product Lead. 
  • Provide technical and clerical support to the production team in the preparation of documentation, collation of data. 
  • Own and lead change controls as required by the NPI Project Team. 

Qualifications & Requirements

  • Bachelor's Degree in Science or Engineering and 5+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (i.e. process development, engineering, quality) OR Associate's Degree in Science or Engineering and 8+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role.
  • 10+ years directly related experience in a biotech/pharma manufacturing or manufacturing environment.
  • Detailed technical understanding of fill/finish operations.
  • Experience in managing multiple, competing priorities in a fast-paced environment.

For further information please contact Mick on 086-0435195 or forward details in confidence to jobs@headcount.ie

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