Senior Process Engineer
What are your responsibilities?
- Support 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 Global and local 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 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 Manufacturing Network as required to support Project.
- On occasion, the role requirements may also undertake Project Engineering duties
- Preparation of project related deliverables such as schedules, work plans, equipment cost tracking o coordination of project activities between stakeholders
- Develop automation-process interfaces and support document generation
Who are we looking for?
- Minimum qualification B.Sc./ B.Eng. or M.Sc./ M.Eng. Degree in Chemical or Biochemical Engineering or equivalent discipline; equivalence being defined as a Biotechnology or Industrial Chemistry Degree with the elements of chemical/biochemical engineering fundamentals as applied to biotechnology/bioprocessing
- 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
- Demonstrated management skill in leading a team to deliver a portfolio of scope delivery being task driven and commercially aware
- Experience and Knowledge of C&Q generation/execution processes and operating models
- Excellent communication/presentation/organizational skills
- In-depth understanding of process/project engineering and technologies pertinent to unit operations with particular focus on Bulk Biological Upstream unit operations, including Seed train design, Bioreactor design, Media and Buffer preparation, Centrifugation, Homogenisation, Purification, Mobile Process Vessels, Bioburden reduction/Sterile Filtration and CIP/SIP.
- Knowledge on the application of Disposable Technologies
- Knowledge of DCS / PLC process control platforms and industry SDLC methodology Notes:
- The role will require an extended period of travel to initially support project design. It is anticipated that this will entail up to 30-40% attendance 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 the Netherlands for site-critical phases thereafter.
What does QbD offer you?
- A young and dynamic company with a feel good culture, and a great openness and a no-nonsense approach
- Real investment in people through education and fun events
- A competence development model focused on your personal ambitions
- An attractive salary package
Interested? Apply now by sending us your CV and motivation.