Process Engineer – III
eTeam Inc
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.
€5000 – 8000 per month
Innishannon, Co Cork
Thu, 23 Jan 2025 23:01:10 GMT
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