DST Controls

Working in DST’s Validation Group for Johnson and Johnson (Jannsen, Vacaville, CA).
to deliver the highest quality of products and services to our clients

Prepare validation plans, protocols and reports following cGMP guidelines. 
Protocols include FAT, SAT / Commissioning, IQ, OQ, PQ, and FQ for cleaning, process, equipment and facility. 
Write design documents (URS, SDD and FS), traceability matrix, and FMEA.
Coordinate validation activities with various functional groups.
Oversee and execute approved protocols following cGMP and GDP requirements. 
Review validation area processes and procedures.  Identify deficiencies and potential failure modes for equipment, facility and process. 
Coordinate and manage change control to equipment and related documents.
Interact with Stakeholders, or other functional groups and contractors to make sure projects are completed on-time and within budget. 
Work to reduce cycle time and improve the Overall Equipment Effectiveness (OEE)
Investigate departures, exception reports, and implement CAPAs.
Generate and execute Investigational Protocols (IP) and qualification addendums
Generate and revise SOPs

Sr. Validation Engineer

Tesla / Continental Engineering Quality

Managed 66 employees in fast-paced, electric car manufacturing of both Model S (sedan) and Model X (SUV) manufacturing teams in production areas demanding multi-focus work environments during the graveyard shift.
Developed, maintained, and optimized team efficiency and productivity procedures for Line Assembly crews and parts assemblers. 
Ordered all parts and performed part and process inspections for up to 14 Line Crew Assembly stations. 
Trained Leads and employees to carry out the production and operational needs to produce as many as 140+ vehicles per shift.  Working often 70 hours per week.

Production Supervisor

Hometown Home Services Inc.

Managed team of 12 workers involved with home gardening, home organizing, and large scale cleaning services for Livermore based company. Scheduled all work, interviewed potential candidates, trained team members, ordered all supplies, and tracked billing and customer issues associated with this family owned business. Day to day activities with our customers were often audited to review performance standards.

Manager of Field Operations

Genentech

Provide Engineering Parts and BOM support for Facilities and Maintenance group
Responsible for technical engineering parts verifications for validated drug systems
Perform parts inductions for new capital and lab equipment using SAP (ver.720R)
Review site equipment and audit parts and facilities drawings and Bills of Materials (BOM)
Lead  site maintenance mechanics and MRO parts warehouse staff as Sr. Parts Engineer
Maintained spare parts and other mission critical support for plant Operations. 
Certified Genentech Material Data Subject Matter Expert (MDSME)

Sr. Parts Engineer

Sr. Project Manager/CoGen.Team Leader:
Managed a team of 18 engineers, designers, AutoCAD drafters and Project Managers working on 6 Chevron Cogeneration plants to limit environmental emissions per mandated programs set forth by the federal EPA. Prepared Chevron Management Teams to review design construction drawings, Process and Instrumentation drawings, and plans for plant and site wide construction and remediation projects. This Engineering Team was comprised of 3 separate companies managed by myself as the DST Controls Team Leader. Managed a project budget of $180 Million US dollars for Chevron in Bakersfield California. 

Manager of Manufacturing:
Lead 16 Technicians and Mechanical Assemblers at DST Controls manufacturing facility in Benicia, CA. Manage state-of-the-art Solar Combiner systems assembly and testing. Fabricate and test Industrial Control panels for Reusable Energy Division. Plan and track all planning for day-to-day operations of the manufacturing department. Performed manufacturing bids, proposal development; planning; responsible for ISO and UL compliance. Perform hiring, training, conduct management reviews, and develop customer relations by aligning promises of the Sales Department with capacities of the Manufacturing department.

Manager of Manufacturing / Sr. Project Manager of Cogeneration Project Upgrades at Chevron

LumaSense Technologies, Inc.

Responsible for leading Fiber Optics Temperature Thermometry (FOT) instrument and controls design manufacturing department of 18 Engineers. 
Worked with Engineering VP to set goals for development engineering department and manage complex multi-tasking projects while adhering to project budgetary limitations. 
Lead new product development and FMEA, risk assessments for Manufacturing group. Helped to develop the 1st ever, human body fiber-optic temperature sensor equipment for medical MRI environment. Maintained Design History File (DHF) per ISO 13485 standards, EN60601 compliance, and FDA Project Development.

Program Manager

Johnson & Johnson

Managed Machine Safety Upgrade Group (3 Teams) for Development Engineering with 22 team members at ALZA. 
Budget consisted $12 Million US Dollars. Resulted in returning $2.0 Million to Corporate Finance in 2005. Accomplished 600 safety upgrades on FDA pharmaceutical equipment in 2 years less than the 6 year target completion date. 
Worked alongside other departments, such as manufacturing, operations, validation and quality departments to successfully return drug manufacturing equipment to "safe operational status" within the pilot plant. These safety upgrades were mandated per Johnson and Johnson Corporate Safety.
(This effort earned the department a commendation from J&J Corporate Safety as the "benchmark of machine safeguarding" throughout the corporation in 2006 from Tom Piantek, Director of Equipment Safety).

Supervisor of Machine Safety

As a Project Manager at my previous jobs, I have had accountability for design implementation, project oversight, and execution of multi-million dollar turnkey projects. During that time, I have developed a solid reputation for successfully and profitably managing many numerous concurrent projects through all project phases from conception through completion within targeted cost, schedule, and compliance parameters. 

I am analytical, insightful, and a highly disciplined problem solver with a demonstrated ability to identify and secure project resources, and provide the quality leadership that invokes committed professional participation on all levels. I have earned the respect of my customers, directors, senior managers, and all stakeholders involved. 

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