Process Engineer

DUTIES INCLUDE BUT ARE NOT LIMITED TO:

- Support manufacturing and drug product development by ensuring knowledge is utilized to ensure project delivery. Report this data in an efficient and concise manner that enable appropriate utilization
- Assist the engineering and technical leads to ensure all existing and future equipment meet the technical requirements of the operation.
- Contribute to the selection and integration of new equipment and services ensuring validation and quality requirements are met and the process capability of the equipment is in line with pre defined needs
- Evaluate, manage, and report the process capability of the equipment and services employed in the operation
- Support and develop equipment/services robustness and mange the risks and impact of failure.
- Manage minor projects that include both operational and financial aspects.
- Ensure that all engineering and validation related aspects of the equipment and associated processes are current and to a required standard. The delivery of this in a unified manner to the correct quality and with minimal impact to manufacture is an essential aspect.
- Drive quality, safety and related activities
- Deliver training and support where required to ensure efficient use and deployment of equipment and services

ADDITIONAL RESPONSIBILITIES INCLUDE:

- Thorough scientific documentation, training and knowledge ensure successful use and implementation of new technology at a local level.
- Provide manufacturing operations support to ensure operational quality and safety.
- Manage new technology implement strategy (manufacturing technology and IT) to increase the flexibility
- Focus on providing immediate troubleshooting/manufacturing support during manufacturing operations at a local level.
- Completing and controlling GMP documentation such as (Change Controls, Batch Records, Logbooks, SOP's etc).
- Development of operational processes/systems and associated standard operation procedures.
- Ensure all operations are executed according to OSHA safety standards.
- Responsible for contributing to departmental technical/GMP/safety training initiatives.
- Responsible for identifying and resolving quality concerns and contributing to the subsequent investigational reports within the quality system
- Contribute to Global Initiatives

SKILLS:

4-7 years Product Testing/Verification experience required

- Experience in Preparation and execution of qualification and validation protocols for solids dosage equipment and computer systems.
- Experience Developing and reviewing standard operating procedures, specification and test methods.
- Ability to manage multiple activities and to keep project timelines is required.
- Bachelor or Masters in an Engineering/Pharmaceutical Sciences/Chemistry discipline.
- Experience in an equivalent role may also be considered with supporting relevant qualifications.
- Experience of drug product manufacturing, equipment qualification, computer control systems and process development is expected.
- Some Formulation knowledge is preferred.
- Understanding of scale-up and technical transfer coupled with experience of troubleshooting and issue/management/resolution.
- Suitable understanding of engineering operations including, instruments, controls and mechanical aspects of pharmaceutical manufacturing equipment and associated services.
- A knowledge of GMP and management of quality through quality systems.
- Experience of Hazop, FMEA, RA (etc) and the utilization of these in equipment and service management.
- Working knowledge of validation and life cycle management of equipment.
- Planning and organizational skills to manage the operational and financial aspects of minor projects at a local level.
- Good interpersonal, organizational and communication skills (both oral and written) and demonstrated skills in team Matrix working. Proven ability to deliver technical reports and presentations.