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Qcs Staffing

Tech Transfer Engineer

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Lead tech transfer and validation for drug substance manufacturing in a large-scale biopharma plant.
10 days ago ago
Expert & Leadership (13+ years), Experienced (8-12 years)
Contractor
Dublin, County Dublin, Ireland
Onsite

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  • Experience in delivering recruitment services for large infrastructure and energy projects.
  • Specializes in sourcing skilled professionals for both permanent and temporary roles.
  • Recognized for working on complex and large-scale projects with a diverse client base.
Role

Description

protocol development
technical studies
process validation
troubleshooting
manufacturing investigation
stakeholder partnership
  • To generate documentation protocols and lead the execution of plant supporting studies and technical studies on the manufacturing floor at commercial scale
  • Authoring of technical documents, including protocols, reports and SOPs supporting the validation of the manufacturing process.
  • To provide on the floor support for troubleshooting processing issues and to lead manufacturing investigations into process deviations and resolution
  • Can effectively partner with and influence stakeholders without direct solid line authority. Drives technical decisions balancing product quality and operational requirements.

Requirements

cgmp
bsc
tech transfer
biopharma
communication
drug substance
  • Have a thorough knowledge of the science behind the molecule and associated drug substance manufacturing processes with fundamental knowledge of the following relevant principles:
  • Good interpersonal skills coupled with demonstrated ability to effectively work in a cross-functional global environment matrix organisation, and in local group settings.
  • You have demonstrated awareness of cGMP compliance and regulatory agency requirements as well as strong oral communication and technical writing skills.
  • Minimum BSc or equivalent with extensive experience in drug substance manufacturing technical support in the biopharmaceutical industry including tech transfer preparation, execution and post-execution activities.
  • Ability to develop, build, present and defend technical and scientific approaches in both written and verbal form.

Benefits

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Training + Development

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About the client

About the client

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