Process EngineerLocation Cork, Ireland Apply
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
We have an exciting opportunity as a Process Engineer/Senior Process Engineer where this individual contributor would fill the role of a system owner for Packaging and Labelling equipment onsite, and work as part of Process Engineering team to support Drug Substance, Drug Product and Packaging & Labelling operations at the Shanbally location. The BioMarin Shanbally site is growing rapidly across Drug Substance, Drug Product and Packaging, and we are keen on people development and continuously improving our ways of working, and always aim for best in class.
- System owner for all packaging equipment and associated automation recipes required for packaging operations
- Process Engineering system owner representative on key capital projects for area expansion currently being implemented in Packaging across different suites. Provide SME input as part of capital project team on design, qualification, cycle development and GMP release
- Implementation of equipment recipe updates required for artwork updates, SKU launch activities and technology transfers of new products
- Provide technical engineering expertise to Packaging process including equipment performance monitoring, equipment recipe standardization, troubleshooting and process optimization
- Lead and support the investigation and resolution of equipment investigations, ensuring appropriate and effective CAPAs are put in place.
- Lead and participate in cross-functional teams to troubleshoot and resolve technical issues, drive continuous improvement, and process optimization using tools such as DMAIC, SMED and FMEA.
- Support the Packaging Operations team to deliver uninterrupted supply of commercial product.
- Provide coaching and support to the Packaging Operations and Process Engineering team to build their packaging equipment knowledge.
- Partner with serialization SMEs to ensure Packaging is ready to meet changing global requirements.
- Participate in cross-functional project teams to ensure project and site stakeholder inputs and requirements are clear and reflected in design deliverables.
- 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.
- Conduct 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.
- Ensure that all manufacturing methods and practices are consistent with industry and BioMarin standards.
- Bachelor’s degree in Engineering; Process, Chemical, Mechanical or equivalent discipline.
- 5-8 years of engineering experience leading initiatives, with a GMP/GCP compliant Biopharma operations experience required.
- 3+ years of directly related experience in relevant Packaging & Labelling environment.
- Experience with process improvement or (six-sigma) and lean manufacturing practices leading to operational excellence, a plus
- Experience of project lifecycle activities to include the qualification of equipment in conjunction with Project Engineering teams.
- Knowledge of PLC and vision systems.
- Strong knowledge of cGMPs (US & EU), OSHA, ISO, and other regulatory agency standards and requirements applicable to a pharmaceutical production facility.
- Experience with change control process and implementing change on engineering systems.
- Demonstrated ability to partner with other functional groups to achieve business objectives required.
- Superior communication skills – Oral, written and formal presentation skills with senior management, middle management and line staff.
- Creative problem-solving skills.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.