QUALIFICATIONS
Engineer with background in pharmaceutical operations and considerable experience in various types of technical writing. Strong analytical, communication and computer skills. Experienced in leading and managing multiple projects. Excellent ability to learn new areas quickly and effectively.
WRITING SKILLS
Experienced technical writer. Documents have included:
• Technical Procedures - integrated package for environmental, health, safety and quality control auditing; plant-wide instrument calibration program; detailed sampling directions; testing procedures; monitoring well closure directions; environmental remediation workplans
• Validation Protocols - revision of proposed SOP's and writing of all validation procedures for computerized pharmaceutical application
• Operating Manuals - automated coating pan control system; ZDCS (vertical market application)
• Regulatory Responses - contributions to NDAs and INDs; official comments on proposed rule-makings; permit applications
• Policies and Standards - chemical releases; secondary containment; inactive site management; environmental training; disposal guidelines for third-party sites; spill notification
• Publication of Original Research - Critical Flow of Nitrogen and Water Through a Nozzle , and Extractive Distillation of Nitric Acid with Magnesium Nitrate (both from Oak Ridge National Laboratory)
• Software Documentation - work-in-progress and final release documentation of custom applications through multiple revisions
Languages include: English (native), German (conversational), Spanish (technical).
COMPUTER SKILLS
Excellent computer skills. Familiar with various operating systems (Linux, Windows; eCS, OS/2 Warp; DOS). Proficient in many office programs, including MS Word and Excel. Familiar with image processing software such as Photoshop and Photosuite and web site tools such as Dreamweaver.
EXPERIENCE
MWC ENTERPRISES 1999 - present
Computer Consultant. Provided various consulting services to manufacturing and service businesses, including training on new software solutions. Handled a variety of projects, from MSDS collections to network installation of proprietary software. Wrote reports and recommendations.
• Software Documentation - Managed documentation packages for multiple revisions of ZDCS, PMRA, MBA, and Thumbkin.
• Training Materials - Co-wrote and edited Moderator's Guide for Ilink network.
• Web Design - Developed web presence for specialty manufacturing companies.
AMERICAN CYANAMID CO. / AMERICAN HOME PRODUCTS CORP. 1993 - 1999
Senior Environmental Engineer. Supported two domestic manufacturing plants and over a dozen third-party facilities in complying with regulations and limiting environmental liability. Supervised consultants and field contractors in US, Latin America and Japan. Issued regular project status reports and schedule updates.
• Auditing - Conducted audits of third-party distribution, formulation, and packaging facilities to insure quality, reduce liability, improve compliance, and screen out unacceptable facilities. Wrote extensive reports for each audit. Devised audit tracking system and wrote integrated audit packages which proved so successful they were extended to international divisions. Trained others from US and Latin America in auditing.
• Risk - Wrote final report evaluating community exposures and assessing risk for ongoing release of benzene. Report was successful in making case for low level of risk, requiring no further action by regulators.
• Waste Disposal - wrote guidelines for manufacturing and packaging waste streams from multiple product lines that led to more consistent disposal practices and cost savings. Developed record-keeping system to track status of hazardous waste disposal projects. Recognized twice with the Cyanamid Innovation Award.
• Regulatory Advocacy - on behalf of both American Cyanamid and Chemical Manufacturers Association, wrote formal responses to regulatory rule-making proposals. Managed document change control.
PFIZER, INC. 1986 - 1992
As Environmental and Process Engineer, then Pharmaceutical Division Chemical Hazard Coordinator, worked closely with three production plants to carry out various projects and assumed responsibility for overseeing and assisting them in complying with environmental and chemical safety regulations. Provided pharmaceutical manufacturing support for chemical, formulation and packaging activities.
• Managed validation project for plant-based computerized in-process label production system, including revision of SOPs, design and execution of test protocols, performance of vendor audit, design of change control system, and writing of all supporting documentation.
• Wrote environmental sections for NDAs and INDs.
• Developed written instrument calibration program to successfully answer FDA deficiency assessment.
SCHERING PLOUGH CORPORATION 1983 - 1985
Project Engineer. Responsible for design, field supervision, testing and startup of manufacturing and construction projects in New Jersey, Ireland and Mexico. Supervised staff of two engineers.
• Built $1.0M solvent recovery plant to recycle two solvents from steroid manufacturing process.
• Managed construction of new $450k quality assurance facility in Mexico, on time and within budget.
EDUCATION
MIT, two years Graduate School in Chemical Engineering, 1981-1983.
The Cooper Union, B.E. in Chemical Engineering, 1981. Minor in Environmental Engineering.
