Process Engineer

Process Engineer

BioMarin

Cork, Ireland

Process Engineer/Senior Process Engineer - reports to the Senior Manager, Process & Automation Engineering and is responsible for ensuring process engineering activities are implemented in a compliant manner. Provide process engineering services to Packaging in a Drug Product, Packaging & Labelling facility.

RESPONSIBILITIES

  • Provide technical engineering support to Packaging process including process performance monitoring, troubleshooting and process optimisation
  • Provide technical engineering support for process fit to plant workshops to ensure successful technology transfers of new products
  • Support the Packaging team to deliver uninterrupted supply of commercial product.
  • Partner with serialisation SMEs to ensure Packaging is ready to meet changing global requirements.
  • Lead and support the investigation and resolution of process investigations, ensuring appropriate and effective CAPAs are put in place.
  • Support product and SKU launch activities.
  • Support tech transfer projects into Packaging.
  • Participate in cross-functional project teams to ensure project and site stakeholder inputs and requirements are clear and reflected in design deliverables.
  • Lead and participate in cross-functional teams to troubleshoot and resolve technical issues, drive continuous improvement and process optimisation using tools such as DMAIC, SMED and FMEA.
  • Required to comply with Company Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day to day activities.
  • Ensure relevant metrics are in place to effectively monitor and report out on operational performance and identify/implement improvement opportunities quickly.
  • Ensure relevant documentation is prepared and updated in line with all Quality and regulatory guidelines and promotes full compliance to all GMP, environmental and safety requirements.
  • Work collaboratively to drive safe, high quality, and cost-effective manufacturing facilities.
  • Instill the use of Right First Time (six-sigma) and lean manufacturing practices leading to operational excellence.
  • Ensure adherence to high standards of quality and support of a science and risk based quality culture.
  • Provide coaching and support to the Operations team to build their knowledge.
  • Ensure that all manufacturing methods and practices are consistent with industry and BioMarin standards.
  • Maintain professional and technical knowledge by attending workshops, reviewing professional publications; establishing professional networks and participating in professional societies.
    • As required supplement Process Engineering team by providing technical engineering support to Drug Product manufacturing including process performance monitoring, troubleshooting and process optimisation.
    • Other duties as assigned.

EDUCATION

  • Bachelor Degree Engineering Process, Chemical, Mechanical or equivalent discipline.
  • Other continuing education initiatives highly desirable (e.g. Six Sigma, Lean Manufacturing, industry specific coursework).

EXPERIENCE

  • At least 8+ years GMP/GCP compliant Biopharma operations experience required.
  • 5+ years of directly related experience in relevant Packaging & Labelling environment.
  • Experience of project lifecycle activities to include the qualification of equipment in conjunction with Project Engineering teams.
  • In depth knowledge and experience of Packaging & Labelling processes and equipment.
  • Knowledge of PLC and vision systems.
  • Experience in drug product filling beneficial.
  • Proficient in the operation of all equipment used in the respective functional area of responsibility.
  • Demonstrated ability to partner with other functional groups to achieve business objectives required.
  • Strong knowledge of cGMPs (US & EU), OSHA, ISO, and other regulatory agency standards and requirements applicable to a pharmaceutical production facility.
  • Superior communication skills – Oral, written and formal presentation skills with senior management, middle management and line staff.
  • Creative problem-solving skills.
  • Comfortable and effective working indirectly through others.

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© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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