- Reference: CJ44331
- Job Type: Permanent
- Location: Cork, Cork City, Munster
- Category: Science, Pharmaceutical & Food
The Process Scientist supports all aspects of a product life cycle from development through to commercial manufacturing. This role will involve working within the Site technology team and will require the following activities:
- Support and lead, were applicable, programmes for the introduction & development of new products into the commercial facility
- Support the process of manufacture of existing and new products
- Support validation activities within the scope of Site technology
- Support all aspects of a product life cycle, including development, registration, clinical and commercial manufacture
- Support the Site Technology department in meeting departmental and site KPI’s
- Support the various Site Technology functions including development facility and Site Technology Analytical Laboratory.
- The role will also support all aspects of new technology introduction, development, plant performance, process improvements, GMP & EHS compliance.
The product support element of the position will involve the following activities:
- Investigation of the events that may have an impact on product quality
- Creation of study plans, protocols and report for product related activities
- Support/generation of the annual product review for products
- Generation or update of production batch records
- Creation or update of SOPs required for the manufacturing of a product
- Support the introduction & development of new products
- Trending of process data and correction of product issues
- Support plant performance activities on site in particular process optimisation initiatives
The role will require the following responsibilities with respect to the Technical support:
- Assist in the selection of the appropriate technologies to support the product manufacture
- Support the selection process for introduction of new production equipment
- Support/lead the process of the introduction of new equipment
- Develop SOPs to support the new equipment
- Train operators and other personnel in the new technologies
- Liaise/co-ordinate/support the validation activities associated with the introduction of new equipment, process or technology
- Be familiar with the products, the manufacturing techniques and procedures.
- Ensure Production Batch Records and SOPs are kept updated and in compliance with regulatory filings.
- Trend all manufacturing yields, key process parameters, etc.
New Product Support
The responsibilities with respect to the introduction of new products will include the following:
- Support the development programmes for new products
- Creation of study plans, protocols and reports for product related activities
- Generation or update of batch records
- Creation or update of SOP required for the manufacture of a product
- Investigation of events that may have an impact on product quality
- Providing technical guidance/support on equipment selection and improvements
- Trending of process data and compiling development data
- Supporting the execution of development trials, Design of Experiments, QbD etc.
- Managing the manufacture of clinical, stability, registration and validation batches
- Develop and validate robust processes for manufacture of new products covering all aspects of product development including registration, clinical manufacture and validation
- Provide the scientific support suitable for the evaluation of novel formulations
- Generate test data to characterise trial formulations and to facilitate product support and scale up studies
- Develop and implement project plans for the manufacture, in-process testing and finished product testing associated with Site Technology projects and stability monitoring programmes
- Record all information, raw data and results accurately, neatly and in a timely manner, in line with procedures
- Conduct all tasks in a responsible way and with due regard to all health, safety and environmental regulations
- Implement and maintain manufacturing processes and associated systems in compliance with GMP and regulatory requirements.
Analysis of New Products
- Co-ordinate the analysis of raw materials, in-process materials, manufacturing data, finished product and scientific data in compliance with schedule and GMP requirements
- Calculate results and report the data, including trend analysis as required
- Execute analysis of scientific data as required
- Co-ordinate new product introduction activities in the scale up facility, where applicable
- Provide operational support to the development facility
Meeting Quality Standards:
- Ensure activities are executed in line with site procedures and in compliance with requirements of cGMP.
- Keep up to date on regulatory standards.
- Lead process investigations into failures, out of trends and out of specifications as required, ensuring corrective actions are implemented
- Be familiar with and apply industry best practices
- Be responsible for upholding departmental & site quality compliance standards
– Ensure that SOP’s are applied.
– Record training for procedures.
– Notify QA about any deviation.
– Carry out corrective actions.
Improve/Optimise Production Efficiencies
- Review with the aim of improving on all production cycle times and yields
- Support and were necessary, lead projects to achieve defined objectives.
Reporting and Communication:
- By reporting and communication to manager in timely fashion any events or incidents.
- By participation in preparation of reports.
- By completing checking of data to ensure accuracy and compliance.
Providing Support for Validation Activities:
- Write and execute the re-qualification protocols of Production/Site technology equipment.
- Write and/or review validation SOP’s for equipment, automation, cleaning and process validation.
- Prepare and/or review / or execution of process and cleaning validation protocols
- Prepare and execution of cleaning, equipment, utilities and facilities validation protocols.
- Provide support and documentation required as part of change control activities.
- Organise the review and approval process for validation documentation.
- Act as designee for the Site Technology Manager
- To work in compliance with regulatory requirements FDA, IMB, GxP, Safety and environmental legislation.
- Support Quality programmes and act as Site Technology representative at site change control meetings.
- Interaction and support with project groups
- Assist in the Training of individuals in the execution of validation protocols
- Position will involve the development of multifunctional skills in the area of equipment, control system and computerised system validation
- Perform/assist in the performance of the Supplier Audits
For a confidential discussion and more information on the role, please contact Rory Walsh on 021 4911063 or email email@example.com
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