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Yyyyyy x. yyyyyy


8705 Yvonne Court Way Xxxxxx, Xxxxxx xxxxxx Telephonexxx-xxx-xxxx


Results-focused Technical Professional with an MBA eager to contribute strong project management, engineering, and quality assurance background toward supporting a dynamic company in achieving

critical business goals and objectives.




Adept in technical project coordination, quality engineering and management, supplier relations, staff/team leadership, strategic planning, and customer relationship management. Solid knowledge of project management methodologies as well as project risk management, procurement, quality control, status reporting, and financial/budget management. Considerable experience in spearheading a project s QA functions, laboratory equipment, and software development and deployment. 6+ years experience in validation and quality assurance. Member of ASQ and PMI.


Selected Achievements:


         Actively participated in cost reduction (calibration) program featuring outsourced work which saved company approximately $120K annually.

  • Championed equipment maintenance procedures that elevated efficiency at BioReliance via Total Preventative Management Program resulting in company savings of $200K/year and increased equipment longevity.

         Performed validation efforts on AMES equipment to boost productivity by 15% in labs and 10% in QAU.

         Recognized as SME for validation of equipment, facilities, and computer systems.

         Partnered with operations team to install a critical component on Provantis system which saved $5K per month in operations costs and decreased QA auditing by two days.

  • Functioned as Project Lead in revitalizing audit process to yield over 90% right for first-time practices.
  • Successfully slashed audit practice from 7-10 days to a 1-2 day processing timeframe.


Professional Experience


BioReliance Corp., Rockville, Xxxxxx, 2006 to Present

Senior Quality Engineer

  • As Interim Manager for QA department, provide critical direction and support while playing an active role in interviewing, hiring, mentoring, and evaluating departmental staff.
  • Exercise strong analytical abilities to evaluate best practices and work processes, swiftly resolve discrepancies, and formulate spreadsheets to identify and implement measurable standards.
  • Closely monitor compliance with government regulations while supervising team of eight.
  • Create PowerPoint presentations, reports, and spreadsheets for senior management, and chosen to spearhead high-level priority projects.
  • Handpicked to coordinate  equipment validation move following reorganization.





Yyyyyy x. yyyyyy Page 2 of 2


Professional Experience continued


        Negotiate contracts, devise project schedules, determine deliverables, and track milestones.

        Serve as Project Manager for departmental relocation initiatives.

        Hire, train, evaluate, coach and direct team of eight in various development projects.

        Complete and submit project status reports to senior management.

        Control validation of computerized systems spanning EDMS, LIMS, ERP, COTS applications, and systems patch and database upgrade efforts.


Senior Validation Engineer

         Led technical validation support through comprehensive assessments, expertly leveraging standard validation engineering techniques and procedures.

         Defined, implemented, administered and approved IQ, OQ, and PQ protocols.

         Resourcefully established and evaluated milestones for validation department in seamless cooperation with Quality Assurance staff and Program Lead.

         Monitored efforts of contractors, subordinate engineers and project managers.


Stelex/TVG (Alpharma, BMS, Pfizer), Bensalem, Pennsylvania, 2004 to 2006

Validation Engineer Consultant

  • Oversaw IQ, OQ and PQ protocols to validate new and improved pharmaceutical equipment.
  • Performed statistical analysis, scrutinized deviations, and led corrective action.

         Conducted final review of test data and reports to ensure compliance with SAT and FAT.

         Devised systems and tools to considerably enhance and accelerate product testing procedures.

         Participated in commissioning, implementation and validation of new equipment.

         Prepared Master Validation Plans and ESD (Equipment Specification Documents), and supported CCR (Change Control Requests) and CAPA (Corrective and Preventative Action Plans).


Prior Experience includes roles as Surgical Technologist II, Administrative Assistant to Vice-President, and Armed Security Officer.


Education & Training


University of Xxxxxx, University College, Xxxxxx, Xxxxxx:

  • MBA, 2010
  • MS in Management ~ Concentration in Project Management, 2009
  • BA Degree, Psychology, 2003, National Dean s List


Frederick Community College, Frederick, Xxxxxx:

  • Certification in Surgical Technology


Training: ASQ, CGMP, GDP, GLP, FDA rules/regulations, pharmaceutical validation in manufacturing & packaging departments

Software/Systems Training: EDMS, LIMS, Trackwise, SDLC (System Design Life Cycle), Mercury Automation tools, Waterfall Model


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