Senior Process Engineer - 12 Month Contract (TEMPORARY)
Location Cork, Ireland Workstyle Onsite Only ApplyBioMarin 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.
Senior Process Engineer - 12 Month Contract
Onsite Role - Shanbally, Ringaskiddy
Closing Date: 26th March 2025
We have an exciting opportunity for a Senior Process Engineer to support Drug Product Filling Operations as part of the Process Engineering team onsite at Shanbally. This is a great opportunity for someone to be a part of a site where we where we are expanding our site capabilities to meet growing demand by qualifying multiple products on our new Drug Product filling line and supporting Drug Product Technology Transfers. Our 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.
The Senior Process Engineer - reports to the Senior Manager, Process Engineering and is responsible for ensuring process engineering activities are implemented in a compliant manner. Provide process engineering services to Manufacturing in a Biologics Drug Substance, Drug Product Filling, Packaging and Labelling facility.
The main areas of responsibility are as follows:
- Provision of technical engineering support to Drug Product Filling operations including process performance monitoring, troubleshooting process investigations and process optimisation.
- Fulfil system ownership responsibilities for assigned Drug Product Filling equipment including production recipe and cleaning recipe updates where required.
- Provide technical engineering support for process fit to plant workshops to ensure successful technology transfers of new products
- Participate in cross-functional project teams to ensure project and site stakeholder inputs and requirements are clear and reflected in design deliverables and support qualifications as required.
- 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.
- Provide coaching and support to the Drug Product Filling Operations and Process Engineering team to build their knowledge.
- 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.
- Instil 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.
- Ensures that all manufacturing methods and practices are consistent with industry and BioMarin standards.
- Maintains professional and technical knowledge by attending workshops, reviewing professional publications, establishing professional networks and participating in professional societies.
- Other duties as assigned
Education and Experience:
- BSc Degree in Engineering - Process, Chemical, Mechanical or equivalent discipline
- Other continuing education initiatives highly desirable - Six Sigma, Lean Manufacturing, industry specific coursework
- 5-8 years of leading engineering initiatives in a GMP/GCP compliant environment.
- Biopharma operations experience required.
- 3+ years of directly related experience in Filling Operations.
- Strong knowledge on 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, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.