Process Engineer

PE Global is currently recruiting for a Process Engineer for a leading multi-national Biotech client based in Carlow.

This is an initial 11-month contract position.

ROLE:

• Manage multiple projects at Carlow from scope development, design, build/install and qualify through to handover to operations for key Engineering projects at Carlow
• Use scientific, product and process understanding as a basis for developing risk-based approaches to investigations and troubleshooting that will feed into future projects
• Develop project scope, cost and delivery time schedule for projects, working and collaborating closely with NPI leads to ensure integration into ongoing Validations and/or technical transfers.
• Collaborate closely with cross functional teams to establish scope in improvement projects at Carlow as we ramp up to a fully commercial site.
• Be accountable for equipment design and qualification; assisting in C&Q execution planning; system boundary definition, system level and component criticality impact assessments, use of quality risk management, User Requirement Specs. And requirements traceability matrices, Document Mgt. Systems, FAT/SAT and C&Q protocol development, project implementation Drive and support continuous improvement by active participation in projects, system failure investigations and investigation reports, execution/development of change control, and contribution to Kaizen events as appropriate.
• Act as a liaison with both global engineering services and facilities as well as specialist vendors to deliver projects on time and in full as required by the business.
• 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.
• Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance Work collaboratively to drive a safe and compliant culture in Carlow.
• Collaborate with multiple partners (e.g., Company network groups, third parties, vendors, quality, donor sites, Supply chain, IPT).
• Presentations and reporting out on progress of projects to stakeholder as required.
• Managing vendors for work on site ensuring compliance with safety and permitting requirements for all on site activities.
• May be required to perform other duties as assigned.

REQUIREMENTS:

• Bachelor’s degree or higher preferred; ideally in a Science, Engineering or Other Technical discipline
• Green Belt preferable
• Would have engineering and/or validation experience in a sterile manufacturing environment and have a proven track record in leading a technical team through sustaining operations and technical transfer projects
• In depth knowledge and experience of Sterile filling processes and equipment especially aseptic processing
• Experience of executing and/or managing through equipment and process design and validation in a sterile environment

Interested candidates should submit an updated CV.

Please click the link below to apply, call Seán on +353 21 4297900 or alternatively send an up to date CV to sean.molloy@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***