Seeking a leadership role in a developing company environment with an opportunity to foster the development and growth of the companyâ€™s products and its technical organization; and whose philosophy is based on teamwork, education, and advancement. Where utilizing my extensive background in engineering and process management, materials development, process improvement, process control, laboratory management will provide valuable contributions to the companyâ€™s organizations.
Ingeborg Anneliese Fernau
Experienced professional with successful engineering and process management track record in a start-up environment as well as high volume manufacturing. History of improvement in high technology manufacturing. Highly skilled in working with multiple disciplines and diversities. Created an innovative product and improved the operational environment. Demonstrated strong organization abilities in all aspects of management and supervision, communications, goal alignment methodologies and achievement. Recognized as a leader who believes we all can make a difference! A positive can-do, "get the job done" attitude is a requirement! Extremely motivated to embrace new technologies.
â€¢ Firm understanding of ISO 13485:2003, 21 CFR Parts 11 & 820 & cGMP
â€¢ Extensive knowledge of analytical analysis (including instrumental, surface & manual)
â€¢ Exceptional analytical skills
â€¢ Managed medical device manufacturing (Class I & III)
â€¢ Process Engineer in Semiconductor environment
â€¢ Product development of pharmaceuticals
â€¢ Excellent communication & documentation skills
â€¢ Sound management and people skills
â€¢ Six Sigma Green Belt Certified â€¢ Proficient in Microsoft Office applications, Microsoft Project, Visio, Minitab and JMP, strong computer literacy aptitude
â€¢ Formulations and process development of thermoplastics, sealants, adhesives and injection molding plastics
â€¢ Proven skill in managing phases of technical projects, establishing processes, defining tests and procedures and providing successful project recommendations
â€¢ Detail oriented and data/results driven
â€¢ Bilingual; fully fluent in German and English
10/2008 â€“ 5/2009 Proteus Biomedical. Hayward, CA
Sr. Manufacturing Manager - Consultant
â€¢ Reviewed processing schedules and production orders. Managed inventory requirements, staffing requirements, work procedures, and duty assignments, considered budgetary limitations and time constraints.
â€¢ Engaged in problem solving in complex situations and process improvements in streamlining work processes. Prepared company for implementation of lean manufacturing.
â€¢ Identified and implemented improvements to reduce costs, cycle time and inventory levels.
â€¢ Managed and maintained the production control procedures / SPC.
2008 â€“ 10/2008 Proteus Biomedical. Hayward, CA
Process Systems Administrator - Consultant
â€¢ Drive the selection of the MES system and create a data system to pull pertinent process data to support business needs.
â€¢ Develop real time performance metrics and process control.
â€¢ Write and review validation protocols and reports.
2007 â€“ 2008 Nektar Therapeutics. San Carlos, CA
Manager Maintenance Systems
â€¢ Manage all preventative and corrective maintenance schedules throughout the year and for the annual shutdowns.
â€¢ Manage GMP services.
â€¢ Establish operational objectives and work plans and delegate assignments.
â€¢ Procuring and scheduling of all contractors as surge resources for day-to-day and annual shut down events.
â€¢ Assure all systems associated with GMP equipment / facility maintenance is in compliance and ready for PAI inspections from many countries including US, Asia and Europe.
â€¢ System owner / administrator of the Maximo maintenance program
2002 â€“ 2007 Nektar (Aerogen Inc.) Mountain View, CA
AP Process Manager
Plating Chemistry Consultant
â€¢ Direct and facilitate all activities related to aperture plate, aerosol generator, and finished medical device manufacture
â€¢ Successfully met and exceeded manufacturing operation plans and objectives
ï‚§ Managed the master schedule for production demand
ï‚§ Balancing the line increased manufacturing output by 2X.
ï‚§ Implemented manufacturing efficiency and capacity metrics. Efficiency increased to 95% and capacity by 50%, which resulted in higher component production
â€¢ Manage implementation and execution of process control protocols
â€¢ Facilitate implementation and application of quality systems to meet medical industry and regulatory body requirements. Team member of the Change Control Board
â€¢ Supported process optimization and yield improvement activities on current processes
ï‚§ Spearhead analytical method characterization and testing of plated technology components
â€¢ Stabilized the pre-plating, plating and chemical maintenance protocols for Palladium Nickel plating solutions
ï‚§ Increased wafer harvest by 3X, and decreased cycle times by 30%
ï‚§ Established SPC controls for bath process monitoring
ï‚§ Improved product quality through SPC review
â€¢ Technical Services Role for the Commercial CSD-2 system to support on-going operations.
â€¢ Lead exception investigations pertaining to Commercial Spray Drying.
1998 â€“ 2002 CANDESCENT Technologies, San Jose, CA
Manager â€“ Chemical Operations
â€¢ Managed the chemical operations of proprietary processes, such as lift-off, wet etch, strip, track 1, litho, halo, dry etch, thin films, ceramics, phosphor slurries, lacquer and screening, used to manufacture Field Emission Displays (Thin CRTâ„¢)
â€¢ Outsourced chemical solution preparation and improved yield by 35%
â€¢ Team Leader for incoming chemicals quality. Pioneered implementation of a complete supplier management system for chemicals including method development and analysis.
â€¢ Cost management: plan and track budget, manpower and external resources
â€¢ Changed chemical suppliers and generated cost savings for Candescent of $300K/year
Additional Skills/Course Work:
Statistical Process Control, Measurement Systems Analysis (Gage R&R), Design of Experiments, Problem Solving Tools, FMEA, Validation, Lean Manufacturing, Read Rite TQM and PIT, Team work & Team Building, Risk Management, ISO 13485:2003 Internal Assessor Workshop, JIT and Kanban
Bachelor of Science in Chemistry, Poulsen Nautrup College for Chemistry and Physics
Patents & Attributes
ï‚§ Method for photo-imageable lacquer deposition for a display device to bind Phosphor in Thin FED (patent pending)
ï‚§ The corporative teamwork to design and develop equipment to enable Digital Equipment Corp. Cupertino site to be the first company to analyze and control the brightener component in an acid copper-plating bath
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