Process Scientist | Collins McNicholas

Process Scientist

  • Reference: CJ44331
  • Job Type: Permanent
  • Location: Cork, Cork City, Munster
  • Category: Science, Pharmaceutical & Food

Job Description

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.

Product Support

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

Technical Support

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

Scale up

  • 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 rory.walsh@collinsmcnicholas.ie

For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie

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Rory Walsh

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  • Rory Walsh
  • Cork Regional Manager
  • 021 4809118
  • Connect with Rory
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