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Expert is a licensed Professional Engineer, Certified Packaging Professional, Certified IRCA ISO 9000 Lead Auditor, and an ISPE Member. He is fluent in Spanish, and a working knowledge of Italian.

2005 to 2009

URS Washington Division

Industrial/Process

Consulting Engineer V

He worked as Project Manager and provided consulting services working within the chemical, pharmaceutical and biotechnology industries. He actively participated in Business Development in the pharmaceutical and biotech industry to provide engineering, procurement, construction management, and commissioning and qualification services to a global client base.

2002 to 2005

Mustang Tampa, Inc

Pharmaceuticals and Biotech

Director of Engineering and Technology

Responsible for the engineering, design and validation group for the Philadelphia operations, recruitment, professional development, resource assignment, project financial performance, developing new clients, preparing proposals and presentations and advising project design teams in accordance with technical, schedule, quality and cost goals. Business Development activities included market research for biotech and pharmaceutical clients, preparing Strategic Account Plans to define our approach to market our services tailored to the clients' needs and our capabilities. Utilize network of contacts within the biotech and pharmaceutical to obtain opportunities to present our capabilities and project approach. Obtained Approved Vendor status for key biotech and pharmaceutical clients that led to proposal submittals and contract awards. Develop, prepare proposals, presentations, Lunch & Learns, attend company booth at tradeshows, and client entertainment activities.

1995 to 2002

Washington Group International, Inc.

Industrial/Process Pharma

Principal Engineer

He is responsible for the engineering, design and validation activities for pharmaceutical, medical device and biotech clients. He is responsible for project financial performance, developing new clients, preparing proposals and presentations and advising project design teams in accordance with technical, schedule, quality and cost goals.

1993 to 1994

SmithKline Beecham Pharmaceuticals, Co.

Packaging Engineering/Design

Senior Manufacturing Equipment Engineer

He managed major capital projects aimed at maximizing production efficiency, minimizing costs, and improving product quality. Developed designs and specifications for one-of-a-kind equipment systems, reviewed vendor bids, recommended awards, and oversaw fabrication, installation, and start up. He led the implementation of capital projects including internal authorizations and coordination of outside suppliers and contractors. He managed the communication and established the technical requirements with vendor project teams. His project management responsibilities included assisting in the start up and validation of manufacturing and packaging contract services for lyophilized and powder anti-infective products. He negotiated a collaboration agreement with a major equipment supplier to develop a long-term partner relationship with negotiated terms and conditions.

1991 to 1993

SKF Labs

Packaging

Packaging Technical Advisor

He coordinated the first ethical to OTC launch for SKF; the Tagamet® HB™ Over-The-Counter launch, managing project capital resources for packaging process start up. He developed departmental strategy to implement technology plan for the automation, replacement, and upgrading of existing packaging equipment. He coordinated with corporate packaging engineering to standardize and consolidate package presentations to facilitate automation, improve efficiency, and reduce costs. Coordinated and supervised clinical packaging runs to support Corporate Clinical Supplies Group. He prepared capital authorizations, specifications, negotiated pricing and terms and conditions with suppliers, coordinated the installation and operational qualifications for capital equipment projects. He maintained constant contact with packaging engineering group to obtain their involvement and feedback with regard to operations improvements and continuous improvement initiatives. He prepared contract packaging and manufacturing feasibility studies to determine potential project costs.

1989 to 1991

SKF Labs

Technical Services

Manufacturing Engineer

He managed the preparation and control of departmental budget. He worked with team of four manufacturing engineers and technicians involved in automation and continuous improvement projects with an annual budget of $2+ million. His projects addressed solid dosage manufacturing, parenterals, prefilled syringes, ampoules, ointments, suppositories, oral liquids, packaging operations, and warehouse automation. He evaluated new technology applications for implementation, developed packaging component sheets and material specifications, coordinated stability testing and set-downs, selected alternate materials for primary and secondary packaging components, standardized components and sources to reduce unit cost, coordinated equipment selection, installation, qualification, and validation activities. He provided industrial engineering support to optimize manufacturing by simplifying the process, and determining optimum machine process capability.

1988 to 1989

MOVA Pharmaceuticals, Inc

Packaging/Warehouse

Packaging Supervisor

He is responsible for the effective communication and management of client expectations for all contract packaging operations for Merck & Co, and effective utilization of resources to meet production requirements. He coordinated the selection, installation, qualification, and validation of packaging equipment; started up new operations and a second shift; hired and trained personnel; provided cost analysis for potential manufacturing/ packaging contracts. He provided industrial engineering support for production areas. He developed the Standard Operating Procedures (SOPs) for the use of the automated production and inventory control software Fourth Shift. Established carrier services for shipping of Finished Goods. He developed the SOPs for warehouse and packaging operations.

1983 to 1988

Searle & Co.

Packaging

Packaging Supervisor

He led operating personnel in the accomplishment of production requirements, cost savings, and continuous compliance with cGMPs. He provided industrial engineering support to the packaging department. He developed and implemented cost reduction and efficiency improvement initiatives. He coordinated procurement and installation of high-speed blister machines for packaging oral contraceptives. He prepared computer reports and assisted in the preparation of departmental budgets. He assured area compliance with cGMPs and SOPs.

• He managed the technical resources to define the optimum operating parameters for the manufacturing process using mixers, eductor valves, ion exchange column, filtration, liquid filling equipment, and heat seal packaging systems to produce a new medical device used to prevent scar tissue development after specific surgical interventions. Managed project financials to meet cost and profit targets. He coordinated the execution of all Installation Qualification, Operational Qualification, and Performance Qualification protocols for the complete manufacturing process. He assisted in performing Design of Experiments to define optimum operating parameters for each process step.
• He analyzed existing storage and material handling operations of the PVC resins manufacturing process to define alternatives for process improvements to reduce cycle times in the loading/unloading of materials into silos, trucks, and railcars. He defined solutions to problems related to segregation of fines in blended materials, material handling, reduction in cycle times to load, unload trucks and railcars and storage conditions, i.e. temperature and humidity. He implemented Industrial Engineering, and lean manufacturing techniques to simplify the process.
• He provided guidance to management with respect to cGMPs in fermentation and purification processes. He prepared, investigated and developed action plans to address manufacturing deviations prior to FDA Pre-Approval Inspection. He developed strategy for the manufacturing team to perform a gap analysis in level of cGMP compliance, as well as auditing, training, documentation. He acted as QA Representative to provide guidance for the evaluation and approval of Process Deviations Reports following cGMP and FDA guidelines.
• He managed the engineering design disciplines in the development of a Master Site Plan for the existing Searle, Ltd. facility in Barceloneta, Puerto Rico. His evaulation included spatial analysis for current and future requirements for manufacturing, central utility plants, compliance issues including ADA, cGMP, local and UBC Building Code. He led the development of a computer model to identify capacity constraints and calculate supply requirements for the existing utility systems that were based on future increases in facility square footage.
• He managed the installation and start up of a parenteral packaging line starting with vial inspection machines, labeler, thermoformer, cartoner, checkweigher, bundler, and case sealer and shipper label printer/applicator. He coordinated the exchange of vendor data to provide Validation group with information to be used in the validation documents and final report. He coordinated the assistance in IQ/OQ and PQ of equipment vendor service technicians to support the Validation team in the execution of protocols.

• Expert in OTC Packaging.
• FDA expert for consulting on FDA Product registration.

He performed a systematic evaluation of data related to an industrial labor accident as a result of a lawsuit against an engineering company that performed construction management services for an industrial manufacturer. He presented final report to the legal counsel of the engineering company that resulted in eliminating their exposure in the lawsuit.

• Expert witness in enzyme fermenation for consulting on pre and post filter presence of lipids, protiens and fats.