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BioMarin Pharmaceutical Inc.
Associate Manufacturing Engineer
Location: Novato,
California
94949
Posted on:
9/25/2009 2:41:48 PM
Postion type:
Full time
Job Code:
09-0078
Required Education:
NOT PROVIDED
Salary:
DESCRIPTION
BioMarin Pharmaceutical Inc.
At BioMarin, we recognize and value each employee’s contribution toward reaching our corporate mission—to develop and commercialize innovative biopharmaceuticals for serious diseases and medical conditions. To this end, we strive to provide employees with a work environment that supports their personal and professional growth. We value the spirit of teamwork and collaboration, encourage honest and open communication amongst all employees, and recognize and celebrate the successes that we work so hard to achieve. We hold ourselves to high standards, and we seek employees who expect excellence in themselves and those around them.
Today, with three products on the market and many other opportunities in our pipeline, there remains a lot of work to be done. We are committed to maintaining a motivated team and to providing a challenging and rewarding career opportunity for every individual who joins us.
EEO/M/F/D/V
To apply: Visit www.BMRN.com Job Code 09-0078
Summary
BioMarin’s Novato commercial manufacturing operations produce recombinant enzyme replacement proteins using perfusion based mammalian cell culture processes and multiple column purification systems.
The Associate Manufacturing Engineer will support the buffer preparation and purification areas. The position requires self-motivation, excellent communication, and strong organization skills. The Associate Manufacturing Engineer will work closely with the Purification Manager, four Purification shift supervisors, Cell Culture and Manufacturing Compliance in meeting commercial manufacturing objectives.
Under the direction of the Purification Manager, the Associate Manufacturing Engineer will be responsible for supporting and coordinating project, technical and operational goals per cGMPs, BioMarin policies and department standards. . Projects will include process improvements, equipment replacement, corrective actions, safety enhancements, and reliability improvements. In addition the position will contribute to or lead complex investigations to determine root causes and corrective actions. The Associate Manufacturing Engineer will also lead continuous improvement efforts with Lean Sigma tools and statistical process control.
The Associate Manufacturing Engineer will be accountable for providing technical support within the Purification group and will interface with Commercial Manufacturing Management and Supervision, Manufacturing Compliance, Manufacturing Sciences, Corporate Compliance, Quality Assurance, Quality Control, Validation, Facilities, Engineering, Materials Management and Purchasing.
Responsibilities
• Work closely with the Purification Manager and four Purification shift supervisors
• Broad understanding of downstream process theory, equipment operation and compliance
• Working knowledge of biopharmaceutical manufacturing process including:
o Tangential flow filtration, depth filtration, column chromatography, bulk drug formulation, buffer preparation disposables and other aspects of downstream processing.
• Ability to troubleshoot equipment failures and support resolution for processing issues
• Initiate and manage technical projects in the Purification group
o Ability to independently manage assigned projects and deliver results with expectations
• Coordinate engineering, maintenance and technical support for Buffer and Purification areas
• Lead continuous improvement efforts via Lean Sigma tools and statistical process control.
• Function as technical trainer for enhancing staff knowledge
• Initiate discrepancies, perform root cause failure analysis and implement corrective action
• Write, modify and implement Standard Operating Procedures
• Initiate change requests for equipment and process changes, modifications and replacements
• Perform regular audits of Purification and Buffer facilities
• Maintain and report Key Performance Indicators
• Incorporate new technologies, practices and standards into procedure
• Strong understanding of cGMP as related to commercial operations
• Experience and or capable of learning and supporting new systems (Process historian, LIMS, Trackwise, ERP, MES, etc.)
REQUIREMENTS:
Education
B.S. in technical field, preferably in chemical or mechanical engineering or acceptable equivalent combination of education and experience.
Experience
• 2-5 years of relevant experience in biopharmaceutical manufacturing, project management, maintenance or engineering
• Strong technical understanding of tangential flow filtration, depth filtration, column chromatography, bulk drug formulation, CIP, buffer preparation, disposables and other aspects of downstream processing
• Working knowledge of process automation and associated equipment
• Proven organizational, leadership and communication skills
• Self-motivated individual, able to work well in a team
• Ability to independently manage work, actions and expectations is essential
• Ability to solve complex technical problems
• Ability to handle multiple tasks concurrently and be flexible and adaptable
• Ability to meet deadlines
• Understanding of lean sigma tools and statistical process control; Green belt preferred
• Understanding of FDA/EMEA cGMP guidelines pertaining to biopharmaceutical or aseptic processing
To apply: Visit www.BMRN.com Job Code 09-0078
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