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Will typically operate as a sole contributor at a local level contributing to department and cross group activities. Will input to cross department initiatives and activities. Will be a recognized SME in certain aspects with a matrix management approach. Colleague will work closely with Operational and Technical leads in the manufacturing group, Global Operations (GO) Quality (QA) Drug Product Design (DPD) to support the manufacture of clinical supplies and developmental activities. Responsible for equipment, computer validation and process support. Preparation and execution of qualification and validation protocols for equipment, mechanical, computer control and utility system. Conduct Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) of process equipment and manufacturing system. Equipment and utilities will be maintained and validated to the required standard. All relevant HAZOP/FMEA/CAT/RA evaluations delivered. Associated spares management and external SME contacts are in place to manage issues.
A consolidated view of the equipment and processes will be managed and delivered and will include but not be limited to all engineering, maintenance, validation, and quality management. Equipment and processes will be managed to ensure they meet the technical and operational requirements in a robust and reliable manner. To utilize quality management systems to ensure efficient capture and closure of quality related aspects including change control Appropriate data is gathered and communicated to demonstrate control of equipment and processes. Data will be used in a diagnostic and predictive manner. Will have a full understanding of the processes and equipment utilized within the unit operations as well as the associated service.
Educated to a degree level in an engineering/scientific/pharmaceutical industry 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 trouble shooting 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.
Education Level Preferred:
Bachelor or Masters
Engineering / Pharmaceutical Sciences / Chemistry
DUTIES INCLUDE BUT ARE NOT LIMITED TO:
Support manufacturing and drug product development by ensuring knowledge is utilized to ensure project delivery. To 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. Deliver these within Pharmaceutical system and guidelines with minimal adverse impact and maximum ROI
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 CI 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 (QTS).
Contribute to Global Initiatives (DPS, DPD, PGS)
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