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 Process Engineering Team to act as client owner representative to deliver integrated process engineering services to meet the Project Objectives.
The Senior Process Engineer will manage cross functional teams to deliver a significant suite or multiple suites of related process scope.
Core Duties and Responsibilities:
Support GES Process Lead to implement a Process Design based on the scope of Process Requirements provided by the Technology and Manufacturing owners.
Lead 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.
Act as client owner representative to self-execute critical design deliverables and provide direction & oversee design progression by an Architect & Engineering design firm.
Develop Process Flow Diagrams, P&IDs, User Requirement Specifications and Equipment Specifications to ensure Process Descriptions/Needs are met.
Manage team to complete process safety deliverables including PHA (Hazops).
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.
Develop and/or review system lifecycle documents including Criticality and Risk assessments, 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 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.
This is a contract position. Estimated assignment duration is approx. 24-36 months, with initial 12 month contract.
The position is based at the MSD Brinny Site for detailed design, execution and qualification activities.
Location may be flexible between Brinny and AE location (TBC) during earlier design phase.
The role will require periods of travel to support vendor reviews & FATs, and periodic attendance at Architect & Engineering Firm offices (location TBD). Flexibility is required in this regard.
Minimum Qualifications and Experience:
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 8 years post academic process engineering experience in relevant aseptic/sterile 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 operations including Closed-Process Formulation, Depyrogenation Tunnel, Isolated Filling, Capping, Automated Parts Washing, Autoclave Sterilization, Mobile Process Vessels, Bioburden reduction/Sterile Filtration, and CIP/SIP.
Knowledge on the application of Disposable Technologies.
Knowledge of PLC process control platforms and industry SDLC methodology.