Chemical Engineer

A.

Role Summary:

• Provide process engineering services in support of the design, construction, commissioning and qualification of a Sterile Formulation and Filling Facility. The job-holder works with the MSD Process Engineering Team to act as client representative to deliver integrated process engineering services to meet the Project Objectives.
• The Process Engineer will assist in the management cross functional teams to deliver a significant suite or multiple suites of related process scope.

B.

Job Responsibilities:

· Support GES Process Lead to implement a Process Design based on the scope of Process Requirements provided by the Technology and Manufacturing owners.

• Support cross-functional project teams to ensure project and site stakeholder inputs and requirements are clear and reflected in design deliverables.
• Ensure all project stakeholders are informed and consulted on key process suite activities and decisions.
• Monitor progress of process suite team milestones with all team members and provide status reports to project Tiers and stakeholders.
• Support the Architect & Engineering design firm to:

o Develop Process Flow Diagrams, P&IDs, User Requirement Specifications and Equipment Specifications to ensure Process Descriptions/Needs are met.

o Support process safety deliverables including PHA (Hazops).

o Ensure MSD Global and Carlow site engineering standards, procedures and practices are followed in the design development.

· Support GES C&Q Lead to coordinate preparation and lead FATs/C&Q field execution.

o Develop and/or review system lifecycle documents including Criticality and Risk assessments, FAT documentation, and C&Q documentation.

o Support 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 MSD Manufacturing Network as required to support Project.
• On occasion, the job-holder may also undertake Project Engineering duties including:
• preparation of project related deliverables such as schedules, work plans, equipment cost tracking
• coordination of project activities between stakeholders

C.

Education/Experience Requirements:

• 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 sterile or aseptic manufacturing.
• Minimum of 3 years post academic process engineering experience in relevant aseptic/sterile processing design, construction & start-up environment.

· Demonstrated ability to be a team player

· Excellent communication/presentation/organizational skills

· Understanding of process engineering and technologies pertinent to unit operations including Automated Parts Washing, Autoclaving, Buffer Preparation, Formulation, Single Use Technology, Bioburden reduction/Sterile Filtration, and CIP/SIP is an advantage

· Knowledge of PLC process control platforms and industry SDLC methodology

D.

Notes:· This is a contract position. Estimated assignment duration of an initial 11 month contract.

• The position is based at the MSD Carlow Site for detailed design, execution and qualification activities.
• The role will require periods of travel to support vendor reviews & FATs, and periodic attendance at Architect & Engineering Firm offices (Cork). Flexibility is required in this regard.