Project Manager Engineer

GERALD VOLKIN

***** **** ***** *****, *** Diego CA 92131

Home 858-***-**** Cell 916-***-**** **********@*****.***

SUMMARY

Experienced Operations Director and Senior Chemical Engineer with a reputation for excellent interpersonal,

Lean Manufacturing implementation and Six Sigma skills. More than 20 years experience managing companies

during critical periods of change: industry downturn, rapid expansion and ownership change. Degreed Chemical

Engineer with experience in managing improvements in high technology products and processes,

pharmaceuticals and biopharmaceutical systems.

Broad background in directing high quality, clean and cGMP manufacturing, work flow improvements,

process plant troubleshooting and project management. Hands-on style manager and project leader

familiar with designing, troubleshooting, validation and managing within FDA guidelines.

Expert at managing improvements in the supply chain, scheduling, logistics and shipping/distribution.

Expert in Kaizen methods of process improvements and Lean Manufacturing techniques. Specialist in

improving productivity, quality and product yields by utilizing 5S and root cause analysis.

Directly responsible for obtaining ISO9001 certification at two high technology manufacturing facilities.

Certified Auditor for conducting internal and on-site supplier audits and reviews.

PROFESSIONAL EXPERIENCE

Director of Operations and Lean Manufacturing Coldpack Systems, San Diego, CA 2007 - present

Directs the improvements in manufacturing, product yield, inventory management, logistics and safety.

Coordinate all aspects of the supply chain and distribution between European and US operations.

Company manufactures and markets highly engineered systems used for cold chain transportation of

pharmaceuticals, APIs, medical devices and thermally sensitive items.

Initiated Kaizen methods and Lean Manufacturing; numerous projects that resulted in a reduction in

headcount of 40% and reduction in overall scrap of 30+%. Exceeded corporate goals for KPIs each year.

Leader of the turnaround program that took the company from multi-million loss to break-even.

Converted inventory management to a Kanban system increasing inventory turns by 200%.

Responsible for product quality and reliability improvements and new product development.

Coordinates new process developments for products in partnership with key clients and customers.

Formulates cost structure, margin analysis and new product pricing. Successfully implemented many

new products into company’s portfolio.

Led the successful implementation of ISO9001-2008. Qualified and certified key raw material suppliers

and conducted internal and external supplier audits.

Initiated and implemented a barcode system for all raw and in-process materials that locked down

inventory accuracy and gave complete product traceability from raw materials to palletized product.

Director of Operations, Rippey Corp. (Acquired by ITW Corp), El Dorado Hills, CA 2002-2007

Directed all Class 100 Clean Room manufacturing, logistics, shipping, facility and project management,

design and development, safety, process improvement and customer satisfaction in a multi-shift, cGMP

and ISO9001 certified facility. Responsible for custom fabrication and assembly operations, packaging

and shipping.

Initiated and led many projects focused on continuous process improvements using Kaizen techniques

which increased overall product yield from 50% to 85+%.

Successfully directed 5 engineers, 7 production supervisors and over 80 manufacturing and machine

shop personnel. Coordinated maintenance activities, CNC fabrication and all purchasing functions.

Led project team that converted company to a Kanban inventory control system increasing annual

inventory turns of raw and intermediate goods by over 50%.

Significantly improved safety record in a hazardous and flammable chemical environment.

Key team member that was awarded certified supplier status with largest customer (Intel).

Key member on transition team when the company was acquired by a Fortune 200 company (ITW).

Senior Project Engineer/Project Manager, Eichleay Engineers, Concord, CA 2001 – 2002

Project Manager responsible for many client’s expansions, upgrades and process improvements in the

biopharmaceutical, fine chemical and petrochemical industries.

Performed project management and process engineering on large domestic and international projects

including a huge facility on-site safety and risk analysis in Peru.

Performed Failure Mode and Effects Risk Analysis on a multi-mile pipeline complex in the Philippines.

Assisted in the design, fabrication and construction of a novel, barge mounted, off-shore thermal

oxidizer system for petrochemical off-gasses in Long Beach, CA.

Senior Project/Process Engineer, Process Facilities Inc (acquired and moved), Sacramento, CA 1999 –

2001

Managed engineering projects at a key client (Aerojet Fine Chemicals) producing pharmaceutical

reactive intermediates (API) in a cGMP contract manufacturing facility. Total build-out was over $22

million. Included scale-up of existing processes and design, construction and validation of new

processes. Included was purification of biopharmaceutical products, fluid bed reactors, precipitation,

CIP systems and fill operations.

Assisted in the design and responsible for construction management, validation and start-up a highly

hazardous chemical (sodium azide) processing area.

Designed and implemented process engineering improvements including facilities infrastructure and

environmental effluent systems.

Plant Manager, ChemDesign Inc., Fitchburg, MA 1996 - 1999

Responsible for contract manufacturing, project management, process engineering and safety in a

custom manufacturing facility producing pharmaceuticals and reactive intermediates in a cGMP facility.

Directed Production Supervisors and Engineers in the multi-shift batch and continuous flow facilities.

Coordinated the design, scale-up, engineering, construction ($2.5 million), start-up, validation and

optimization of a new product.

Plant Manager, K.J. Quinn and Company Inc, Seabrook, NH 1991 – 1996

Responsible for manufacturing, project engineering, process design and improvement in a specialty

chemical company producing solvent and water based polyurethane and UV curable polymers.

Assisted ownership in investigating and justifying acquisitions.

Designed and installed new clean packaging line for UV cured optical coatings.

Key player in obtaining ISO9000 certification for manufacturing facilities.

ADDITIONAL PROFESSIONAL EXPERIENCE

Plant and Production Management positions for Continental Brands and Lubrizol Corp.

Massachusetts and Texas

Coordinated multi-plant manufacturing operations, project engineering and logistics.

Implemented SPC and SQC in the manufacturing areas.

Managed operations of Class 100 clean room facility producing ultra-pure chemicals.

Senior role in engineering and start-up of $16 million expansion in Texas and $24 million facility in

India.

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EDUCATION

Bachelor of Science, Chemical Engineering, Northeastern University, Boston, Massachusetts

Skilled in Microsoft Office Suite.

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