Process Engineer

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 (eg. 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.
• Required to 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.
• Required to be compliant via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance.
• To lead and execute process engineering and validation activities to support the technical transfers.
• To lead and manage multiple Technical Engineering projects needed to support the business. This includes but is not limited to: Process improvements, capital projects and Lean projects across multi-disciplined functions which may also require global and network support and collaboration.
• Responsibility to lead an integrated project team in delivering the project business case and collaborating closely with cross functional teams to establish scope in improvement projects as they ramp up to a fully commercial site.
• To 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 trouble shooting.
• 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 looking for synergies and innovative ways of doing work. Constantly assessing our systems and processes to see what improvement we can make to work smarter and more efficiently while all the time being compliant.
• 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
• Min 4 years’ experience ideally in manufacturing, preferably 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 rebecca@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***