* In this role you provide process engineering services in support of the design, construction, commissioning and qualification of bulk biological manufacturing facility. The rol will work as a member of the MSD Process Engineering Team acting as client owner representative, to deliver integrated process engineering services to meet the Project Objectives.
* As a Senior Process Engineer you will manage a cross functional team to deliver a significant suite or multiple equipment packages of related process scope.
* Support GES Process Lead to develop and implement a Process Design based on the scope of Process Requirements provided by the site SMEs and Bio-Process Development Groups.
* Lead a cross-functional project team to ensure project and site stakeholder inputs and requirements are clear and translated into design deliverables.
- Ensure all project stakeholders remain 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 or other).
- Ensure MSD Global and Oss site engineering standards, procedures and practices are followed in the design development and implementation.
* Manage/Support technical client-vendor interfaces for equipment packages
- Ensure process design parameters are fully implemented and tracked
- Ensure vendor design documentation meets defined deliverables requested
* 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 as required.
* 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 role requirements 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
- develop automation-process interfaces and support document generation
* Minimum qualification B.Sc or M.Sc Degree in Chemical or Biochemical Engineering or equivalent discipline. Equivalence has been defined as a Biotechnology or Industrial Chemistry Degree with the elements of chemical/biochemical engineering
* Minimum of 7+ years post academic process engineering experience in relevant biopharmaceutical processing design, construction & start-up environment
* Demonstrated ability to lead/ influence teams in matrix environment
* Experience and Knowledge of C&Q generation/execution processes and operating models
* Excellent communication/presentation/organizational skills
* Knowledge on the application of Disposable Technologies
* Knowledge of DCS / PLC process control platforms and industry SDLC methodology
* The role will require an extended period of travel to initially support project design. It is anticipated that this will require an extended period of travel to initially support project design. It is anticipated that this will entail up to 30-40% attndance at the A&E firm in Ireland (location tbc) for a duration of circa. 12 months. Thereafter, travel will be required for periodic support vendor reviews % FATs with full-time attendance required in Oss for site-critical phases thereafter. Flexibility is required in this regard.
Let op: Agile-1 is tussenpartij en MSP en werken via Acceleration.
Salary based on 40hours
Salaris op basis van 40 uur is afhankelijk van opleiding en ervaring. Hiernaast is er een reiskostenvergoeding, pensioenregeling, 8% vakantiegeld en 25 vakantiedagen op FT basis. De rol is in eerste instantie voor een jaar, maar langere termijn (36 maanden) behoort ook tot de mogelijkheden.
De vacature is voor 40 uur per week.
Uren per week: 40
Salaris: € 327,67
Wil je meer informatie of heb je vragen over deze vacature neem dan contact op met Victor Addotey via firstname.lastname@example.org of bel .