BioMarin Pharmaceutical Inc.
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.
Process Engineer/Senior Process Engineer - reports to the Senior Manager, Process & Automation Engineering and is responsible for ensuring process engineering activities are implemented in a compliant manner. Provide process engineering services to Packaging in a Drug Product, Packaging & Labelling facility.
- Provide technical engineering support to Packaging process including process performance monitoring, troubleshooting and process optimisation
- Provide technical engineering support for process fit to plant workshops to ensure successful technology transfers of new products
- Support the Packaging team to deliver uninterrupted supply of commercial product.
- Partner with serialisation SMEs to ensure Packaging is ready to meet changing global requirements.
- Lead and support the investigation and resolution of process investigations, ensuring appropriate and effective CAPAs are put in place.
- Support product and SKU launch activities.
- Support tech transfer projects into Packaging.
- 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.
- 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.
- 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.
- Provide coaching and support to the Operations team to build their knowledge.
- Ensure that all manufacturing methods and practices are consistent with industry and BioMarin standards.
- Maintain 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 Product manufacturing including process performance monitoring, troubleshooting and process optimisation.
- Other duties as assigned.
- Bachelor Degree Engineering Process, Chemical, Mechanical or equivalent discipline.
- Other continuing education initiatives highly desirable (e.g. Six Sigma, Lean Manufacturing, industry specific coursework).
- At least 8+ years GMP/GCP compliant Biopharma operations experience required.
- 5+ years of directly related experience in relevant Packaging & Labelling environment.
- Experience of project lifecycle activities to include the qualification of equipment in conjunction with Project Engineering teams.
- In depth knowledge and experience of Packaging & Labelling processes and equipment.
- Knowledge of PLC and vision systems.
- Experience in drug product filling 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, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.