3842 Stratford Court
Raleigh, NC 27604
Job Objective To obtain a Process Validation Engineer position in the industry in which to practice and exert my years of experience to better help the company.
Highlights Of Qualifications:
- Extensive experience in executing process validation activities
- Steep knowledge of calibration to carry out validation testing
- Huge knowledge of documentation practices and aseptic technique along with good grasp of mechanical concepts related to pharmaceutical equipment
- Skilled in conducting validation testing – Kaye Validator, thermocouples, and temperature measuring devices
- Solid understanding of windows based software programs
- Ability to coordinate about project status
- Superior interpersonal and time-management skills
- Excellent mechanical, technical and communication skills
Process Validation Engineer, August 2005 – Present
Teva Pharmaceuticals, Raleigh, NC
- Aided defined validation protocols and final report packages.
- Formulated written defined validation protocols.
- Executed validation protocols and outlined final reports and packages.
- Outlined and analyzed SOPs related to validation activities.
- Supervised proper maintenance of test equipment.
Process Validation Engineer, May 2000 – July 2005
Boehringer Ingelheim, Raleigh, NC
- Formulated validation protocols and testing strategy.
- Outlined final report and monitored Standard Operating Procedures.
- Aided quality investigations.
- Handled breakdowns of production equipment.
- Managed critical validations during shutdown.
Bachelor’s Degree in a Scientific or engineering, Everest College, Portland, OR
5258 Hanka Rd
Lamar, CO 81052
Objective To obtain a Process Validation Engineer position in a well established company where my skills will make a positive contribution.
- Strong experience in process validation in a regulated manufacturing environment.
- Extensive experience in process validation and certification of wireless products.
- Solid experience and knowledge of FDA and ISO requirement relating to validation program requirements and validation documentation practices.
- Proficiency with Excel spreadsheets and MS Power Point.
Process Validation Engineer, 2006 to till date
Aaron Industries, Inc., CA
- Performed validation planning activities and tracking for NPI, CPI and cost reduction, coordination and follow up with team.
- Worked around the production department to gain access to production equipment which needs to be validated.
- Designed testing strategy and methodology for the qualification and validated products, cleaning processes, equipment, HVAC systems and utilities.
- Developed, executed and maintained validation methodology in accordance with applicable regulatory requirements and industry best practices.
M.S in Computer Science Engineering, 2006
Carnegie Mellon University
B.S in Biomedical Engineering, 2004
University of California- San Diego