PE Global is currently recruiting for a Process Engineer for a leading multi-national Biologics client based in Carlow.
This is an initial 11-month contract position. This Technical Engineering role will play a key part in the development of our client's drug product facility.
This role is to lead activities to deliver on the Tech Transfer requirements needed to support New Product Introduction.
This includes but is not limited to: Tech Transfer, Validation programs & strategies, Technical support and process improvement projects, network support & collaboration.
Role:
Work collaboratively to drive a safe and compliant culture.
Collaborate with multiple partners (e.g., network groups, third parties, vendors, quality, donor sites, Supply chain, IPT) in achieving excellence in technical transfer programmes.
Serve as technical engineering representative for internal technical group discussions and represent Technical Engineering at Global Technical Forums as required.
Comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current good manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.
Complete documentation, conduct risk assessments, close out corrective actions, participate in audits and inspections, and proactively highlight any issues around compliance.
Lead and execute process engineering and validation activities to support the technical transfers.
Manage multiple Technical Engineering projects needed to support the business, including process improvements, capital projects, and Lean projects across multi-disciplined functions requiring global and network support and collaboration.
Lead an integrated project team in delivering the project business case and collaborate closely with cross-functional teams to establish scope in improvement projects as they ramp up to a fully commercial site.
Manage and deliver on all technical/Validation/Quality Notifications/Change control/Project support within the technical engineering team.
Use scientific, product, and process understanding as a basis for developing risk-based approaches to investigations and troubleshooting.
Sponsor and foster lean six sigma and standard work within the technical engineering team (e.g., Structured Root Cause Analysis, Statistical Process Control, Data-driven decision making).Drive collaboration between group functions and proactively seek synergies and innovative ways of doing work.
Constantly assess our systems and processes to identify improvements for working smarter and more efficiently while ensuring compliance.
Act as a subject matter expert on (1) Equipment Design (2) Assisting in C&Q execution and planning; (3) Process design and validation.
Act as a liaison with both global engineering services and facilities as well as specialist vendors on process requirements to deliver projects.
Requirements:
Bachelor's Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline.
Minimum 4 years' experience ideally in manufacturing, preferably in a GMP setting.
NPI and Tech Transfer experience.
Interested candidates should submit an updated CV.
Please click the link below to apply, or alternatively send an up-to-date CV to
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland.
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