Process Engineer

PE Global; Leinster; On-site; EUR 42,000 - 64,000; Full time

Job summary

PE Global is recruiting a Process Engineer for a leading multinational Biotech client based in Dundalk. This is an initial 9-month contract position.

The role requires leading cross-functional project teams, ensuring C&Q deliverables meet site inputs, and coordinating with stakeholders. You will develop lifecycle documents and oversee installation/start-up through OQ with readiness for PQ/PPQ, while aligning with global engineering standards.

Qualifications

• Minimum 3+ years post-academic process engineering experience in biopharmaceutical processing design, construction & startup environment.
• Ability to lead/influence teams in a matrix environment.
• Understanding of unit process and utility operations for bulk vaccine processing facilities.
• Knowledge of regulatory/code requirements Irish/European/International.

Responsibilities

• Lead cross-functional project teams to reflect inputs in C&Q deliverables.
• Inform and consult stakeholders on process activities and decisions.
• Monitor progress and provide status reports to project tiers and stakeholders.
• Oversee C&Q progression of assigned project activities.
• Coordinate preparation and, at times, lead C&Q field execution.
• Develop/review system lifecycle documents (URS, FAT, C&Q docs).
• Manage installation/start-up/testing of process systems through OQ and PQ/PPQ readiness.
• Collaborate with global engineering services and vendors to deliver projects on time.

Skills

Project leadership

C&Q execution

Regulatory knowledge

Process engineering

Education

B.Sc./M.Sc. Chemical Engineering

Tools

DCS/PLC systems

MES software

Job description

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

This is an initial 9-month contract position.

ROLE:

• Lead cross-functional project teams to ensure project and site stakeholder inputs and requirements are clear and reflected in C&Q deliverables.
• Ensure all project stakeholders are informed and consulted on key process activities and decisions.
• Monitor progress of deliverables with all team members and provide status reports to project Tiers and stakeholders.
• Oversee C&Q progression of assigned project activities.
• Ensure Client Global engineering standards, procedures and practices are followed.
• Support GES C&Q Lead to coordinate preparation and, at times, lead C&Q field execution.
• For new assigned capital projects;
• Develop and/or review system lifecycle documents including Criticality and Risk assessments, URS, FAT documentation, and C&Q documentation.
• Manage installation / start-up / testing of process systems through OQ completion. Interface with cross-functional team to ensure systems’ post-OQ (PQ, PPQ) readiness.
• Liaise with stakeholders, equipment vendors, business partners, and SMEs at other sites within the Client Manufacturing Network as required to support Project.
• The role also involves Project Engineering duties including preparation of project related deliverables such as schedules, work plans, equipment cost tracking coordination of project activities between stakeholders
• Maintain contact with the Project Sponsors to ensure engineering solution development remains aligned with the project’s business case.
• Use scientific, product and process understanding as a basis for developing risk-based approaches to investigations and troubleshooting that will feed into future projects.
• Collaborate closely with cross functional teams to establish scope in improvement projects at Dundalk as we ramp up to a fully commercial site.
• 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.
• Work collaboratively to drive a safe and compliant culture.
• May be required to perform other duties as assigned.

REQUIREMENTS:

• Minimum of 3+ years post-academic process engineering experience in relevant biopharmaceutical processing design, construction & start-up environment.
• Demonstrated ability to lead / influence teams in matrix environment
• In depth understanding of process engineering and technologies pertinent to unit process and utility operations for a bulk vaccine processing facility.
• Knowledge on the application of Filling Line
• Knowledge of DCS/PLC process control platforms and industry SDLC methodology
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
• knowledge and experience of Sterile filling processes or similar manufacturing and equipment
• Excellent report, standards, policy writing skills required
• Automation and MES knowledge
• Proficiency in Microsoft Office and job-related computer applications required
• Having a strong safety ethos
• Minimum qualification B.Sc. or M.Sc./ M.Eng Degree in Chemical or Biochemical Engineering or equivalent discipline; equivalent is defined as a Biotechnology or Industrial Chemistry Degree with basic the elements of chemical/biochemical engineering fundamentals as applied to biotechnology/bioprocessing

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