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Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Our manufacturing and process development teams manage the production of our therapies for clinical trials and commercial markets.
These engineers, technicians, scientists, and support professionals continually provide quality assurance and ensure we meet all regulatory standards.
We have manufacturing facilities in Northern California and in Cork, Ireland.
Additionally, our supply chain teams procure the goods and services needed to support manufacturing and worldwide distribution.
About Technical Operations 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.
Title: Process Engineer Duration: 12 months Contract 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: Provide technical engineering support and expertise to Packaging & Labelling Operations including equipment performance monitoring, equipment recipe standardisation troubleshooting and process optimisation Represent Engineering on the Packaging & Labelling Operations Process Team and support to deliver uninterrupted supply of commercial product.
Fulfil system ownership responsibilities 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 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 optimisation using tools such as DMAIC, SMED and FMEA.
Provide coaching and support to the Packaging Operations and Process Engineering team to build their knowledge.
Partner with serialisation 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 documentation is prepared and updated in line with all Quality and regulatory guidelines and promotes full compliance to all GMP, environmental and safety requirements.
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.
Providing coaching and support to the Operations team to build their knowledge of packaging processes and associated recipes.
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 BA Degree in Engineering
- Process, Chemical, Mechanical or equivalent discipline Other continuing education initiatives highly desirable
- Six Sigma, Lean Manufacturing, industry specific coursework Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position.
It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
To be considered for this role you will be redirected to and must complete the application process on our careers page. xcfaprz
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Sprachkenntnisse
- English
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