Senior Manufacturing Expert
1 week ago
BioMarin Pharmaceutical Inc. is a global leader in developing and commercializing innovative therapies for patients with rare genetic diseases. Our mission is to provide meaningful advances to patients who live with serious and life-threatening conditions. We target diseases that lack effective treatments and affect relatively small numbers of patients, often children. These conditions are frequently inherited, difficult to diagnose, progressively debilitating, and have few or no treatment options. BioMarin remains committed to advancing therapies that are the first or best of their kind. The Technical Operations group at BioMarin is responsible for creating drugs for clinical trials and scaling up production for commercial markets. This includes building and maintaining cutting-edge manufacturing processes and sites, ensuring quality assurance and quality control to meet regulatory standards, and procuring necessary goods and services to support manufacturing. The team also coordinates the worldwide movement of our drugs to patients.
About the Role:
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 our facility. This role involves providing technical engineering support to Drug Product Filling operations, including process performance monitoring, troubleshooting process investigations, and process optimization. Additionally, you will be responsible for fulfilling system ownership responsibilities for assigned Drug Product Filling equipment, collaborating with cross-functional project teams, and leading and participating in cross-functional teams to resolve technical issues and drive continuous improvement. You will also be expected to develop and implement training programs to enhance the knowledge and skills of the team members.
Requirements:
- Bachelor's degree in Engineering (Process, Chemical, Mechanical, or equivalent discipline).
- Strong understanding of cGMPs (US & EU), OSHA, ISO, and other regulatory agency standards and requirements applicable to pharmaceutical production facilities.
- Proven experience in leading engineering initiatives in a GMP/GCP compliant environment.
- Demonstrated ability to partner with various functional groups to achieve business objectives.
- Excellent communication, problem-solving, and interpersonal skills.
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