Solid Dosage Manufacture Production Engineer (P03) - Flexible Working Available
Senior Production Engineer providing technical support to facilities, utilities and equipment used in the development and clinical manufacture of a range of solid dosage forms.
An individual contributor role that applies comprehensive technical and engineering knowledge to develop equipment and process understanding, which may include some validation, safety and asset lifecycle management activities. Colleague will work closely with operational and technical teams across Pfizer to deliver robust manufacturing solutions. Colleague will be expected to interact with Global Operations, Quality Assurance and Drug Product Design to support the manufacture of solid oral dosage forms for clinical supply and solid dose process development activities.
- Colleague will be a recognized SME in certain aspects of equipment or processes with a matrix management approach providing Subject Matter Expertise in multiple focus areas : Automation, Facility support, Process Development.
- Colleague will work closely with operational and technical teams in the manufacturing group to deliver robust manufacturing solutions interacting with Global Operations (GO) Quality (QA) Drug Product Design (DPD) Pfizer Global Sourcing (PGS) to support the manufacture of oral clinical supplies and solid dose process development activities.
- Responsible for manufacturing equipment and process development support which may include preparation and execution of qualification and validation protocols for equipment, mechanical, computer control and utility system. Colleague will support Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) of process equipment and manufacturing systems.
- Undertakes activities associated with provision of process scale up, knowledge management and tech transfer coupled with immediate troubleshooting and complex issue resolution during SDM manufacturing operations.
- Develop and maintain a technology management strategy which includes evaluation of future equipment / technology against user requirement specifications for the operation.
- Collaborate with Global Operations to ensure maintenance of equipment and utilities is carried out to the required standard.
- The role will evaluate, manage and report the process capability of SDM equipment developing an understanding of operating windows and the impact of process parameters on product development. Appropriate data gathered and communicated to demonstrate control of equipment and processes and use of data in a diagnostic and predictive manner.
- Support manufacturing and drug product development by ensuring knowledge is utilized to enable complex project delivery. To report data in an efficient and concise manner that enable appropriate utilization
- Contribute to the selection and integration of new equipment and services, ensuring technical, validation, quality requirements and the process capability of the equipment is in line with pre defined needs.
- Manage minor projects which include all operational and financial aspects. Deliver these within Pfizer system and guidelines with minimal adverse impact and maximum ROI.
- Educated to degree level in Mechanical, Bio Engineering, Biomedical Engineering or Chemical Engineering with minimum 5 years experience in pharmaceutical manufacturing.
- Working knowledge of solid dose formulation and process development.
- Working knowledge of data integrity and demonstrated ability to work on digital projects.
- Comprehensive knowledge of equipment, facility and utility asset lifecycle management from initial design and procurement through to validation and operational use.
- Understanding of process scale-up, knowledge management and technical transfer.
- Evidence of trouble shooting and problem solving of complex issues utilizing lean concepts and 6 sigma or equivalent tools.
- Working knowledge of facility design and associated building management systems.
- Suitable understanding of engineering operations including, instruments, controls and mechanical aspects of manufacturing equipment and associated services.
- A working knowledge of GMP and demonstrated understanding of compliance and quality management.
- Experience of Safe Systems of Work and risk assessment tools used in both Quality & Safety areas beneficial.
- Evidence of planning and organizational skills in the project management of operational and financial aspects of capital projects.
- Good interpersonal, organisational and communication skills (both oral and written) and demonstrated leadership skills. Capable of leading global working teams and developing strategic plans. Proven ability to deliver technical reports and presentations.