Malcolm E. Ramsay

Cell: 484-***-**** Email: ac1y3j@r.postjobfree.com

Objective: A position in process/project engineering in the chemical, food, or pharmaceutical industry that will enable me to utilize my process and project engineering experience.

Education: B.E. Chemical Engineering, City College of CUNY, New York, NY

M.S. Chemical Engineering, Lehigh University, Bethlehem, PA

Experience: Roche Vitamins Inc./DSM Nutritional Products Inc., Belvidere, NJ:

January 1998 – May 2017

Spray Dry Operations –

Process Engineer – June 2014 – May 2017

Responsible for the daily operations of the human nutrition and animal feed spray dry products under cGMP conditions.

Formulated and issued batch sheets for each campaign.

Trained operators on specific steps in the process to ensure products meet all in process and finished product specifications.

Identify and eliminate common causes of process and product variations.

Used lean six sigma tools to trend data from each campaign and reduce process variation as well as to lower assay targets.

Compiled monthly OEE data.

Trouble shooted equipment failures and process upsets and participated in root cause analysis (RCA).

Evaluation and integration of new products to utilize current process and equipment.

Participated in Kaizen events to reduce turn around time between campaigns.

Participated in PHA/HAZOP studies and HACCP evaluations.

Developed and wrote SOP’s for specific unit operations.

Writing of IQ/OQ/PQ protocols.

Fermentation Plant

Plant Performance Engineer – May 2008 – May 2014

Managed capital improvement projects from conceptual design, basic design, final design, to installation and startup. Projects included the refurbish and bringing back into manufacturing two (2) 40,000 gallon fermenters with agitation mechanism all nutrient feed streams. Installation of new 10,000 gallon harvest tank to enable downstream processing to be more efficient. These projects enabled the company to satisfy the increased production demands.

Participated in cross-functional team meetings to ensured projects were completed on schedule and within budget.

Interaction with outside contractors and vendors.

Visit to vendor sites for FAT.

Malcolm E. Ramsay Email: ac1y3j@r.postjobfree.com

Fermentation Plant (contd.)

Use of Microsoft Project to keep project on schedule.

Participated in PHA/HAZOP studies.

Assisted in production startup.

Vitamins Forms Support Laboratory

Technical Specialist – June 2004 – April 2008

Evaluation and optimization of current manufacturing processes to make processes more efficient and effective. Processes include homogenization, emulsification, spray drying, blending, granulation, coating and compression.

Use of statistical process control (SPC) and lean six sigma tools for process analysis and to reduce process variations.

Trouble shooting and root cause analysis (RCA).

Alternate technology and equipment evaluation.

Scale up and technology transfer from laboratory to pilot plant and production scale.

Assist in production startup.

Human Nutrition Premix Plant

Project Engineer – January 1998 – May 2004

Managed capital improvement projects from conceptual design, basic design, final design, to installation and startup. Projects included the installation of 2 slant cone mixers and the relocation of packing operations so that packaging occurs directly out of blenders. These projects enabled the company to satisfy the increased production demands.

Participated in cross-functional team meetings to ensured projects were completed on schedule and within budget.

Interaction with outside contractors and vendors.

Visit to vendor sites for FAT.

Assisted in production startup.

Roche Diagnostics Systems, Belleville, NJ.

Technical Specialist – August 1992 – December 1997

Provided technical support for the Polymerase Chain Reaction (PCR) reagents manufacturing process under cGMP.

Participated in experimental designs to make manufacturing process more efficient.

Trouble shooted and made recommendations to resolve problems encountered during manufacturing of existing and new products.

Developed and implemented in-process tests for the PCR generic bulk reagents and Cobas Amplicor reagents.

Developed and wrote SOP’s for in-process testing and equipment validation protocols.

Malcolm E. Ramsay Email: ac1y3j@r.postjobfree.com

Lampire Biological Laboratories, Coopersburg, PA.

Research Scientist – July 1991 – August 1992

Research and development of a process for the manufacture of stabilized stroma free hemoglobin from bovine blood.

Purification of immunoglobulins and its fragments using affinity chromatography.

Training: Lean six sigma

Project management

ICH Q7A1 GMP Guidance for API’s

Publications: Processing Rice Bran by Supercritical Fluid Extraction.

‘Food Technology’ – November 1991.

Extraction of cocoa butter with Supercritical Carbon Dioxide.

Presented at AIChE Conference of Food Engineering (CoFE) – March 1991.

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