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Senior Process Engineer

Location Cork, Ireland

In Ireland, BioMarin operates a Biopharma Manufacturing Site in Shanbally, Co. Cork, and a Global Commercial Operations Hub in Dublin.

Having just obtained approval to establish Sterile Drug Product Filling operations at the Shanbally site, we at BioMarin are now looking to commence hiring for key technical and leadership positions. Initially these roles will support the capital project execution, product transfers and operational readiness activities before moving into routine operational support. This facility will contain a state of the art flexible line using isolator technology for filling of vials and syringes and the facility will support both clinical and commercial filling for the majority of BioMarin biologics product portfolio. 

We at BioMarin are looking to hire Senior Process Engineer to act as Lead Process Engineer on the Sterile Drug Product Program with a view to successful project delivery and a clearly established support model for ongoing operations.

What makes working here unique? At BioMarin, we feel the intense tie between the work we do and the life-changing results it delivers. Our focus on rare disease gives us the rare opportunity to truly impact lives. As BioMarin employees, we’re here because we want to be here. We enjoy our work — and each other. Our people are smart. Unassuming. Collaborative. Curious. Interesting. In return, there is development, empowerment and total reward.

BioMarin has a high-performing, team based organisation, where colleagues are flexible, multi-skilled and empowered to make decisions. A high level of initiative, energy and motivation are key role requirements, as well as excellent organisational skills.

The Process Engineer is a member of the Process Engineering team who are accountable for the technical engineering support for Drug Substance, Sterile Drug Product and Packaging and Labelling operations.

Key aspects of this role are to provide technical engineering support to the project team ensuring successful startup of Sterile Drug Product operations. Once start up is complete the Process Engineer will have accountability for engineering support ensuring the delivery of sterile drug product from the Shanbally facility across, component preparation, sterile filling and visual inspection operating units. 

RESPONSIBILITIES

    • Provide process design support to ensure successful qualification and operation of a new Drug Product facility.
    • Provide process engineering input to support the manufacture of sterile filled drug products, syringes and vials, on the flexible Sterile filling line at Shanbally.
    • Provide technical engineering support for process fit to plant workshops to ensure successful technology transfers of new products.
    • Responsible for engineering design and optimisation of single use consumables.
    • 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.
    • Ensures 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.
    • Providing coaching and support to the Operations team to build their knowledge of Bio-process engineering.
    • Ensures that all manufacturing methods and practices are consistent with industry and BioMarin standards.
    • Providing coaching and support to the Operations team to build their knowledge of Bio-process engineering.
    • Maintains 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 Substance Manufacturing process including process performance monitoring, troubleshooting and process optimisation. 
EDUCATION
  • Bachelor Degree in Process and Chemical Engineering or equivalent discipline.
  • Other continuing education initiatives highly desirable (e.g. Six Sigma, Lean Manufacturing, industry specific coursework).
EXPERIENCE
  • At least 10+ years GMP/GCP compliant Biopharma operations experience required.
  • 8+ years of directly related experience in relevant aseptic/sterile processing design, construction and start-up environment.
  • Experience of project lifecycle activities to include the qualification of equipment in conjunction with Project Engineering teams.
  • In depth knowledge and experience of Sterile filling processes and equipment especially aseptic processing.
  • Knowledge on the application of disposable technologies.
  • Knowledge of PLC and DCS process control platforms.
  • Experience in drug product packaging and labelling 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.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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