Process Engineer
4 weeks ago
Job Title: Process Engineer - III
Location: Brinny, Cork
Employment Type: Full-Time (Fixed Term Contract)
Duration: 03/03/2025 - 06/02/2026
Company Profile:
A global leader in innovative biopharmaceutical solutions, specializing in vaccine manufacturing, biologics processing, and advanced biotechnological production. The company focuses on state-of-the-art engineering solutions, high-quality manufacturing standards, and cutting-edge research to advance healthcare worldwide. It is committed to sustainable practices, compliance with industry regulations, and continuous improvement in process optimization.
Key Responsibilities:
- Provide process engineering services for the design, commissioning, and qualification of a major expansion to an existing bulk vaccine processing facility.
- Act as a client-owner representative within the Process Engineering Team to ensure successful project execution.
- Lead cross-functional teams to deliver:
- Equipment package design, factory acceptance testing, installation, and commissioning.
- Product vessels, single-use mixers, single-use UFDF skids, and CIP/SIP skids.
Job Responsibilities:
- Support the Process Lead in implementing a Process Design based on defined project requirements.
- Lead cross-functional teams to ensure project and site stakeholder inputs are accurately captured and reflected in commissioning and qualification (C&Q) deliverables.
- Ensure clear communication and alignment among project stakeholders regarding key process suite activities and decisions.
- Track and monitor progress of process suite team milestones and provide status reports.
- Oversee C&Q execution performed by partner firms and ensure adherence to global engineering standards and best practices.
- Coordinate and support C&Q field execution, including:
- Development and review of system lifecycle documents (Criticality and Risk Assessments, FAT documentation, and C&Q documentation).
- Management of installation, start-up, and testing of process systems through OQ completion.
- Ensuring post-OQ readiness for Performance Qualification (PQ) and Process Performance Qualification (PPQ).
- Collaborate with stakeholders, equipment vendors, and business partners to ensure seamless integration of project components.
- Perform project engineering duties such as:
- Preparation of schedules, work plans, and cost tracking for equipment.
- Coordination of project activities between various stakeholders.
Education & Experience Requirements:
- Degree Qualification: Minimum B.Sc. or M.Sc./M.Eng in Chemical, Biochemical Engineering, or equivalent discipline. Equivalent qualifications include a Biotechnology or Industrial Chemistry degree with core chemical/biochemical engineering fundamentals.
- Experience: Minimum of 8 years of post-academic experience in biopharmaceutical process engineering, covering design, construction, and start-up.
- Technical & Leadership Skills:
- Strong ability to lead and influence teams in a matrix organizational structure.
- Excellent communication, presentation, and organizational skills.
- In-depth understanding of process engineering and technologies relevant to bulk vaccine/biologics processing.
- Knowledge and application of single-use technologies.
- Familiarity with DCS/PLC process control platforms (e.g., Delta V) and industry SDLC methodologies.
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