Who We Are

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.

The Role

Process Engineer - reports to the Process Engineering Manager 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 Substance processes including change implementation, process performance monitoring, troubleshooting, process optimisation and project delivery.

Main areas of responsibility:

• Provide technical engineering support to Drug Substance Manufacturing process and Process Teams including process performance monitoring, troubleshooting and process optimisation
• Initiate, develop and implement technical solutions, cost-saving ideas and continuous improvements under the guidance of site change control systems.
• 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 technical engineering support and participate in cross-functional project teams to ensure successful introduction of new equipment and successful technology transfers of new products.
• 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.
• Maintains professional and technical knowledge by attending workshops, reviewing professional publications; establishing professional networks and participating in professional societies.
• 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.
• 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.
• 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
• Knowledge of Delta V process control platform is desirable
• 3+ years experience 
  
  

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.