Lead technology transfer and scale-up for API/intermediate manufacture: facility-fit assessments, process optimization, safety and operational readiness, support HAZOP/FMEA, use process modeling and PAT tools, provide engineering support to R&D and plants, share best practices, and generate process engineering reports.
Role and Responsibilities
PREFERRED SKILLS
Minimum Qualification
Bachelor / master's degree in chemical engineering
Target years of experience
3 to 8 years of experience
Type of experience
Experience in a technical/functional role, Core Team member can be considered
Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Engineering
- Primary role is to drive Technology transfer activities including facility-fit assessment (process mapping), process optimization and operational readiness assessment and provide technical support as SME for successful scaleup of CRD projects in API development with internal & External CMO's.
- Responsible person for an intermediate/API manufacturing development step in scale up.
- Developing equipment fits for a multi-purpose API facility for new and existing products in existing equipment trains. e.g. successful tech. transfer from sister site of a new, high value, high demand API product for commercial scale-up and manufacture.
- Providing end-to-end planning with respect to API supply commitments, short term for casting, including raw material delivery and API release.
- Supporting HAZOP programs, FMEA and Continuous Improvement projects.
- Design and develop safe manufacturing processes for APIs and their intermediates.
- Critically assess the safety of processes intended for manufacture of APIs, and their intermediates, on laboratory, pilot plant and commercial manufacturing scales. This activity is critical to laboratory, pilot plant and commercial manufacturing activities.
- Develop knowledge and experience of chemical reaction hazards, engineering principles and physical organic chemistry to be able to independently liaise with chemists to aid in the design of inherently safe processes and aid in solving process safety and scale-up related challenges as encountered.
- Use process modeling software like Dynochem, Aspen plus, Visimix, DoE/Minitab software for development of scale up from lab to plant scale.
- Familiarize in using PAT tools such as Crystal 16, FBRM, EasyViewer & BlazeMetrics for Crystallization studies and React IR on the Reaction kinetics.
- Using statistical tools to identify, analyze, and interpret patterns and trends in complex data sets could be helpful for the diagnosis and prediction.
- Provide technical/ Process engineering support for R&D and Plant such as corrosion study, mixing study, crystallization study, filtration study, Reaction kinetics and Kla studies for effective scale up.
- Support CRD chemists for their Process engineering studies for scale up batches (Mixing from lab scale to plant scale, filtration studies using pocket filter for selection of filter and their Equipment mapping at higher scale. Handling hydrogenation and Kilo facilities for scale up batches.
- Provide technical engineering support for process fit to plant workshops to ensure successful technology transfers of new products.
- Sharing knowledge between sites with same/similar technology within Global network and Participation in global process technology networks.
- SME in Process Engineering principles and operations with a flair for people management and development skills.
- Collaboration with cross functional team for smooth and safe execution of projects across the sites.
- Support technology transfer activities including process Optimization of infrastructure and operational readiness assessment.
- Generation of process engineering report associated with Technology Transfer.
PREFERRED SKILLS
- Excellent knowledge of chemical engineering unit operations and principles including reaction kinetics, reactor design, chemical thermodynamics, heat and mass transport, engineering statistics, modelling and simulation (Dynochem, Aspen, Visimix etc).
- Excellent knowledge of downstream processing unit operations (extraction, distillation, crystallization, filtration/washing and drying)
- Knowledge of equipment such as Reactors, filters, driers, centrifuges, mills, sieves and filter/driers.
- Data collection and MINITAB analysis experience. Ability to develop data driven root cause analyses and solutions with strong problem-solving skills and an aptitude for learning systems quickly. Able to utilize structured problem-solving techniques such as DMAIC, Ishikawa (Fishbone diagram), Five Why (5W) or Lean six sigma. Able to resolve high level performance issues into addressable actions.
- Strong ability to work and communicate effectively with team and peers within a manufacturing and Process R & D organization. This includes excellent communication skills: written and verbal.
- Competent conducting chemical reactions, work ups and isolations in the laboratory to generate data
- Track record of successfully developing manufacturing processes.
- Excellent knowledge of scale dependent and independent parameters and how to manage scale-up and scale-down experiments.
- Understanding and knowledge of process safety considerations when scaling processes.
- Working knowledge of off-line and on-line analytical techniques (e.g. HPLC, MS, NMR, FTIR, FBRM, UV)
Minimum Qualification
Bachelor / master's degree in chemical engineering
Target years of experience
3 to 8 years of experience
Type of experience
Experience in a technical/functional role, Core Team member can be considered
Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Engineering
Top Skills
Aspen Plus
Blazemetrics
Crystal16
Dmaic
Doe
Dynochem
Easyviewer
Fbrm
Five Why
Ftir
Hplc
Ishikawa
Lean Six Sigma
Minitab
Ms
Nmr
React Ir
Uv
Visimix
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