When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $20 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
In this role you will lead process engineering support for process design, process start-up, trouble shooting and process efficiency improvements, utilizing significant experience in API manufacture and pharmaceutical unit operations. You will also lead capital projects and introduction of new technologies for R&D Cork and develop, train and mentor junior processing engineering staff
What you will do
- SME for plant set-ups, unit operations, troubleshooting
- Working in a HPT partnership with the chemistry and analytical groups to deliver the safe and effective introduction of new/existing chemistry into the Cork Pilot Plant.
- Lead the implementing plant modifications in compliance to R&D and GMS SOPs.
- Managing relevant capital projects from concept through to implementation with responsibility for budget, cost and scope.
- Completing all documentation responsibilities i.e. Process Risk Assessment, campaign summary reports, GMP reviews, PCCE etc.
- Lead the technical resolution of all plant and production issues in the pilot plant, including managing the Eng Ops interface
- Ensure strong engineering contribution to all project activities, helping to install design for manufacture and manufacturability attributes early in the process development.
- Developing the HPT partnership with Process Dev. Engineers and Project Teams. Ensuring that the engineering knowledge is successfully transferred between the pilot plant project teams and to commercial facilities
- Support commercial campaigns outside of the pilot plant as resource requirements change on a site wide basis
- Engaging fully in the science of projects promoting innovation and creativity, while delivering value to the customer and commercial where applicable
- Work closely with the health, safety and environmental team to ensure that the pilot plant is in compliance with site practices.
- Observe pilot scale trials and identify any potential scale-up issues. Develop a plan for ensuring any scale-up issues are addressed / resolved.
- Prepare detailed PFDs, and identify the optimum conditions for scale up and validation of the commercial manufacturing process.
- Agree plant modifications with project engineering area (agree scope, PFDs, P&IDs, Hazop close out etc.) Provide commissioning / start-up support.
- Work closely with development chemists/customers to ensure optimisation of final process.
- Ensure environmental treatment procedures are optimised (initiate solvent recovery trials etc., as necessary).
- Lead trials of new or alternative equipment or technologies that may optimise process
- Interact with customers as required
- Lead the process engineering aspects of plant cleaning set-up and qualification
- Maintain compliance with GMS quality systems. Implementation of equipment modifications and the coordination of qualification and commissioning activities to GMS GMP standards.
- Ensure strong engineering contribution for Technology Transfer activities, Build and maintain the TechDev/Clinical Supply Engineering interface
- .Deliver Technical Excellence pulling significant experience in scale up and manufacture
- Extract maximum value from existing technologies (eg. PAT, DCS) Investigating industry best practice by looking at competitors, suppliers and contract organizations.
- Extract maximum value from global information systems, engineering tools, the integration of automation and data collection strategies to further enhance NCE delivery based on the information derived from plant campaigns.
- Be leaders in Eng. Technology Transfer activities across clinical supply and commercial
- Execution of process engineering efficiency projects.
- Training for pilot plant personnel on new equipment items / modifications.
- Take a lead role in the mentoring and training of new starters in the process engineering team. Responsible for executing the relevant training plan and developing skills and knowledge
- Provide mentorship and support to Process Engineering Placement Students
- Deputise for the Engineering and Operations Manager when required
- Perform the lead investigator role for Quality and Safety investigations
- Lead Audit support/Face the Auditor for both Clinical and Commercial Audits
- Lead Process engineering support for all capital projects in area (agree scope URS, PFDs, P&IDs, Hazop close out, engineering change control etc.) Provide commissioning / start-up support.
- Raise Project Proposals as necessary for both minor and major projects, to improve efficiency / resolve technical issues in area.
- Develop URS for any automation projects in area.
- Identify any large improvement projects for area that need inclusion in site project plan
- Raise/approve engineering change control forms for any changes in area.
How you will get here
- Demonstrated ability to work as part of a cross-functional team. Ability to work across teams and functions.
- Clear communication skills
- Engineering change controls, validation documentation and batch documentation
- The ability to solve problems is a key skill for this role. The ability to use personal knowledge and expertise
- is essential. An understanding of when to escalate issues and when to draw on the expertise of others is
- also required.
- Effective use of problem-solving tools such as RCA is a requirement
- Honours degree qualified in Chemical Engineering Preferred
- B. Eng. Higher degree or other post-graduate qualification in a related subject
At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
Apply today! http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on
the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.