Job Title: Senior Process Engineer

Role Summary:

• Provide process engineering services to support the design, commissioning, and qualification of a significant expansion to an existing bulk vaccine processing facility.

• Act as a client owner representative to deliver project objectives.

• Manage cross-functional teams to deliver the following scope:

• Equipment package design, factory acceptance testing, installation, and commissioning.

• Packages may include product vessels, single-use mixers, single-use UFDF skids, and CIP/SIP skids.

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Job Responsibilities:

• Support the GES Process Lead in implementing a process design based on the outlined process requirements in the project scope of work.

• Lead cross-functional project teams to ensure project and stakeholder requirements are clear and reflected in commissioning and qualification (C&Q) deliverables:

• Ensure all project stakeholders are informed and consulted on key process activities and decisions.

• Monitor progress of team milestones and provide status reports to project stakeholders.

• Oversee C&Q progression by a partner firm.

• Ensure global and site-specific engineering standards, procedures, and practices are followed.

• Support the GES C&Q Lead to coordinate preparation and, when required, lead C&Q field execution:

• Develop and review system lifecycle documents, including criticality and risk assessments, FAT documentation, and C&Q documentation.

• Manage installation, start-up, and testing of process systems through OQ completion and ensure post-OQ readiness for PQ and PPQ.

• Liaise with stakeholders, equipment vendors, business partners, and subject matter experts at other manufacturing sites within the network to support the project.

• Undertake additional project engineering duties, including:

• Preparing project deliverables such as schedules, work plans, and equipment cost tracking.

• Coordinating project activities among stakeholders.

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Education/Experience Requirements:

• Minimum qualification: B.Sc. or M.Sc./M.Eng in Chemical or Biochemical Engineering or equivalent. Equivalent qualifications include Biotechnology or Industrial Chemistry with a foundation in chemical/biochemical engineering principles applied to bioprocessing.

• At least 8 years of post-academic process engineering experience in biopharmaceutical processing design, construction, and start-up environments.

• Proven ability to lead and influence teams in a matrix environment.

• Strong communication, presentation, and organisational skills.

• In-depth understanding of process engineering and technologies relevant to unit processes and utility operations in bulk vaccine/biologics processing facilities.

• Knowledge of single-use technologies.

• Familiarity with DCS/PLC process control platforms and industry SDLC methodology, such as DeltaV.