Engineer Process

ENGINEERING & MANAGEMENT EXPERIENCE

QUALIFICATIONS PROFILE

Motivated engineering professional with a wide range of process, project, process development, and management experience in several manufacturing industries. Work experience includes Food, Pharmaceutical, and Biopharmaceutical industries. Confident and dedicated worker with superior skills in coaching, relationship building, training, developing and managing teams. Excellent communicator with demonstrated ability to excel in cross-functional department teams.

CORE COMPETENCIES

Process Engineering

Project Engineering

Process Development Engineering

Project Management

Project Financials

Team Leadership

Training

Mentoring

PROFESSIONAL EXPERIENCE

Chiquita, Charlotte, NC 3/10/2014 – 5/01/2015

Manager Process Engineering

Lead a team of engineers and financial specialists in order to efficiently and effectively design and develop manufacturing processes and manage spending related to capital projects for five Fresh Express salad manufacturing facilities located across the U.S.

Manage the process for documentation, training and implementation of Engineering processes, procedures and standards.

Oversee the process for generating equipment and facility layout drawings for vendor quoting, design development and final approval.

Provide engineering solutions to plant problems and facilitate the implementation and start-up.

Communicate with cross-functional departments i.e. peers, process engineers, project engineers, corporate project managers, and plant management to obtain project support.

Cambryn Biologics, Sarasota, FL 2013 - 2014

Director of Manufacturing

Responsible for the quality of all products manufactured, filled and packaged at the Cambryn Sarasota facility in Florida in order to produce two lyophilized protein products. Also responsible for the specification, purchase and installation of all capital equipment.

Assisted the R&D Process Development group with the scale-up of the fibrin glue process and provided leadership and support for all process improvement projects.

Reviewed, approved and executed protocols for the IQ, OQ and PQ of the equipment associated with the manufacturing, filling and packaging processes as required by the Validation Master Plan. Also generated the final reports with the necessary attachments for closing the Validation.

Ensure the facility meets all safety and cGMP status in preparation for the production of material for PQ lots.

Supported the QA Environmental Monitoring (EM) program by making sure the manufacturing area is properly cleaned, the HEPA filters are certified, all instruments are calibrated and the rooms are balanced with the correct air exchanges and differential pressures.

Created and executed a training program for sterile gowning which included the operating procedures, ordering and stocking of gowning materials and the use and disposal of gowning materials.

Grifols Therapeutics, Clayton, NC 1996 - 2013

Principal Process Development Engineer / Project Engineer / Process Engineer

Managed projects at the Grifols facility which was formerly Talecris (formerly the Biological Division of Bayer Corporation, a biopharm company specializing in liquid and lyophilized blood plasma products).

Principal Process Development Engineer:

oR&D Lead for the transfer and FDA submission of a product line from a CMO in Berkeley, CA to Clayton, NC. FDA approval was received on 3/23/12.

oManaged the R&D Capital budget (~$7MM in 2011) in order to provide instruments and equipment in support of R&D Objectives.

oManaged a staff of scientists and engineers in the Technology group of the R&D department. Supported technology transfer activities, clinical lot production, risk assessments, training and process development work for several biological projects.

oUtilize unit operations such as lyophilization, chromatography and filtration (including ultrafiltration (UF), diafiltration (DF) and nanofiltration).

Project Engineer / Process Engineer:

oManaged several multi-million dollar projects from the design phase to the installation, start-up and validation of each project.

oSupervised several contract project managers and their staff of contractors hired for engineering, mechanical installation, and electrical installation support.

oOptimized the plasma protein manufacturing process as a Process Engineer / Project Engineer for the following:

Modification of the liquid nitrogen bath (double dipper) used for “cracking” plasma plastic containers in preparation removal of the plastic before a thaw cycle.

Investigated the availability of tanks and agitator systems for thawing plasma. Also performed lab tests at Lee Industries in Pennsylvania and Ross in New York.

Supported the plasma "bags to bottles" project by providing technical evaluation, budget, and scope definition for elimination of the bags used to store the plasma and replacing them with specially designed bottles in order to eliminate product loss. Also visited similar operations at Baxter and Alpha Therapeutics in California.

Bristol-Myers Squibb, Morrisville, NC 1992 - 1996

Project / Process Engineer

Part of a transition team responsible for the installation and start-up of the "Liquid Semi-Solid Department" at the Morrisville, NC over-the-counter drugs manufacturing facility. Project included travelling between New Jersey and North Carolina for almost two years.

Coordinate scheduling of the mechanical, electrical and controls contractors with the Construction Management Group responsible for the relocation of equipment from the plant in St. Louis, MO to Morrisville, NC.

Oversee / assisted with Pilot Plant studies (Hillside, NJ) and full scale development and manufacture of Liquid and Solid Dosage products.

Work with the Maintenance department in order to troubleshoot manufacturing and packaging equipment and correct problems associated with Solid Dosage, Liquid, and Semi-Solid products.

Develop Capital Acquisition Request (CAR) for new equipment.

Review / update GOI's/SOP's and other departmental training instructions.

Manage qualifications and validations at Contract Manufacturing site.

CPC International – Best Foods, Jersey City, NJ 1984 - 1992

Project/Process Engineer and Production Supervisor

Project / Process Engineer:

Directly responsible for the design and successful implementation of several major projects within the allotted budget. Includes factory acceptance testing (FAT) at several domestic and international equipment manufacturers.

Energy coordinator; responsible for all programs in energy saving, progress reports, keeping the plant up-to-date on the latest technology in energy savings and preparing the yearly energy budget.

Worked with Plant Engineering and Maintenance implementing minor projects. Submit monthly progress reports on current projects to the Plant Engineer.

A member of several task forces for the improvement of production throughput.

Production Supervisor:

Supervised 10 employees in the Macaroni and Noodle department while overseeing the operation of 16 extruders and 13 dryers, time keeping, product changeover, regular and weekend work scheduling.

Wrote maintenance work orders and followed-up on the work performed.

Worked closely with the Quality Control department to ensure the production of high quality products.

EDUCATION

Master of Arts Degree, December 1991 Rutgers, The State University of N.J.

Major: Business Administration (MBA)

Bachelor of Science Degree, May 1984 New Jersey Institute of Technology

Major: Chemical Engineering

PUBLICATIONS

Co-authored: “Characterization of Thrombate III, a pasteurized and nanofiltered therapeutic human antithrombin concentrate”; published in the 2014 issue of Biologicals, Journal of the International Alliance for Biological Standardization.

Contact this candidate