Technical Professional
Resume:
Klaus Engelmann
Park Ridge, NJ 07656
Areas of Expertise:
- Tenures included developing a wealth of knowledge of Pharmaceutical Operations such as Terminal Sterilization, Building Management Systems, Clean Steam Generation, Freeze Drying, Depyrogenation, Room Pressurization, and Water Purification.
- Equipment and Instrumentation used in the Pharmaceutical and Biotech industry.
- Strong working knowledge and experience in the application of Blue Mountain Calibration Manager software, Calibration Manager 4 and Microsoft Office and Access, SAP, Crystal Reports, Trackwise, Pilgrim, and other PC applications. Additional skills include use of MP2 and Maximo preventive maintenance programs.
PROFESSIONAL EXPERIENCE
WYETH PHARMACEUTICALS, Pearl River, NY 2007 – 2008
Consultant
Project entailed migrating records from Maximo database to Calibration Manager Database. Designed measurement data templates in Calibration Manager, revised preventive maintenance orders in Maximo Provided metrics, maintained excel spreadsheets,and advised on metrology and instrumentation issues as they related to project completion.
IMCLONE SYSTEMS, Branchburg, NJ 2005 – 2007
Metrology Supervisor
As supervisor, was responsible for six metrology technicians and activities of outside contractors. My group provided direct support to chemistry, engineering, facilities, manufacturing, microbiology, quality control, and validation business units. Daily activities include conducted training in company procedures, reviewing work orders, data sheets, and “out of tolerance” reports. Generated non-conforming event reports, corrective action/preventive action, purchase requisitions, service contracts, and equipment acquisitions/decommissions.
INDEPENDENT CONSULTANT, Park Ridge, NJ 2004 – 2005
Moldieco Plastic Products, Inc., Fords, NJ
Developed and wrote quality procedures in preparation for audits by client firms. Advised on quality issues and represented company during audits.
ORGANON, INC., West Orange, NJ 1989 – 2004
Supervisor, Metrology 2002-2004
Scheduled, planned and coordinated the activities of technicians, contractors, and temporary employees in calibration and maintenance of pharmaceutical process instrumentation. Conducted interviews and performance reviews and trained staff. Coached and graded for performance. Issued and Fulfilled work requests by interface with other departments concerning calibration, application, and repair issues.
Wrote, reviewed and revised all Metrology SOPs (50) using Documentum to maintain documentation compliant to FDA guidelines. Used Crystal Reports in conjunction with Blue Mountain to capture Metrology activities and provided KPIs to senior management.
Specified instrumentation, calibration services, general supplies and services, obtained bids and quotes for each project. Executed the application of accountability systems for vendors, contractors, purchase orders, requisitions, bids, and quotes for each project
Ensured NIST traceability and full compliance of all work to CGMP guidelines, answered all audits, internal and external, resulting in a clear audit record over fifteen years. Issued Out Of Tolerance Notices, Change Controls, CAPAs.
Senior Metrologist 1998 – 2000
Maintained Metrology program, including calibration of pharmaceutical process instrumentation at West Orange and Allentown facilities. Diagnosed and corrected instrumentation problems related to RTDs, thermocouples, transducers, transmitters, recorders, and controllers. Devised calibration test fixtures to improve efficiency. Specified user instrumentation. Issued Out Of Tolerance Notices. Maintained neat and accurate documentation system, ensuring compliance to FDA, ISO, CGMP standards. Trained internal and external persons in calibration procedures.
Metrologist 1991 – 1998
Scheduled and performed all calibrations. Ensured that all calibrations were NIST traceable.
Maintained all Metrology records and documents. Issued Out Of Tolerance Notices.
Validation Metrologist 1989 - 1991
Performed validation studies on depyrogenation ovens and stability chambers. Calibrated all instrumentation at the West Orange Facility including temperature, pressure, vacuum, humidity, resistivity, conductivity, time, pH, and dimensional instruments and performed validation studies on Depyrogenation ovens and stability chambers, Issued completed validation studies for approval and compliant with NIST traceability.
EDUCATION
Caldwell College Caldwell, NJ - B.Sc., Business Administration, Graduated Cum Laude – 1994
Cleveland Institute of Electronics - Electronics Technology - 1983
AWARDS
Quality Awareness Award – 1999
Letters of Commendation
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