Tech Transfer Engineer

3 weeks ago

Dublin, Dublin City, Ireland QCS Staffing Full time

Tech Transfer Engineer - Dublin, Ireland - TBC

One of the top 10 best companies to work in Ireland is looking for a Tech Transfer Engineer for their large-scale new facility in Dublin. An exciting project there is lots of opportunity to learn new technology and develop current skills within a fast-paced €1 billion project. This fantastic client offers the opportunity to work within a large-scale environment with cutting-edge technology.

Responsibilities Include:

  • Deliver tech transfer readiness activities from facility assessment through to PPQ execution and report completion for a new product introduction to the MPCC Cruiserath.
  • Have a thorough knowledge of the science behind the molecule and associated drug substance manufacturing processes with fundamental knowledge of the following relevant principles:
  • Downstream: to include buffer preparation, purification and viral reduction steps including chromatography, ultrafiltration viral reduction filtration and viral inactivation technologies and DS formulation and bulk fill.
  • Authoring of technical documents, including protocols, reports and SOPs supporting the validation of the manufacturing process.
  • Identify and implement process improvements, e.g. yield, cycle time reduction through evaluation of process performance using data analytics tools.
  • Generate documentation protocols and lead the execution of plant supporting studies and technical studies on the manufacturing floor at commercial scale.
  • Provide on the floor support for troubleshooting processing issues and lead manufacturing investigations into process deviations and resolution.
  • Provide process subject matter expertise for regulatory inspections and other interactions with regulatory agencies, representing the Cruiserath site.
  • Document and appropriately communicate aspects of work and learnings at internal and external fora (may include participation at scientific meetings).
  • Identify or support process improvements (through change control or CAPA) and participate in implementation of Lean initiatives at site.

Key requirements include:

  • Minimum BSc or equivalent experience in drug substance manufacturing technical support in the biopharmaceutical industry including tech transfer preparation, execution and post-execution activities.
  • Demonstrated awareness of cGMP compliance and regulatory agency requirements as well as strong oral communication and technical writing skills.
  • Good interpersonal skills coupled with demonstrated ability to effectively work in a cross-functional global environment matrix organisation, and in local group settings.
  • Ability to develop, build, present and defend technical and scientific approaches in both written and verbal form.
  • Can effectively partner with and influence stakeholders without direct solid line authority.
  • Drives technical decisions balancing product quality and operational requirements.

If this role is of interest, please apply now

Seniority level

Entry level

Employment type

Contract

Job function

Engineering and Information Technology

Industries

Staffing and Recruiting

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