Previous Job
Previous
Validation Engineer
Ref No.: 18-00734
Location: Marion, North Carolina
V2Soft (www.v2soft.com) is a global company, headquartered out of Bloomfield Hills, Michigan, with locations in Mexico, Italy, India, China and Germany. At V2Soft, our mission is to provide high performance technology solutions to solve real business problems. We become our customer's true partner, enabling both parties to enjoy success. We are committed to promoting diversity in the workplace, and believe it has a positive effect on our company and the customers we serve.

We have an immediate requirement for a Validation Engineer with our client in Marion, NC.

Required Skills:

Job Requirements:
  • ​Count colony forming units (CFU) on Petri plates.
  • Perform Growth Promotion and inoculum cultures
  • Perform preparation of reagents, materials, and equipment used in microbiological testing in sterile environments, such as HEPA hoods.
  • Maintain accurate and complete test records.
  • Maintain Instrument Usage and Calibration Logs based on instrument usage during the preparation and testing of samples.
  • Maintain current knowledge of regulatory and industry standards, trends and advancements.
  • Conduct method development, method validation and method transfer
  • Demonstrates proficient support in swab recovery studies
  • Supports activities regarding audits of suppliers and contract labs in support of vendor certification program.
  • Conducts statistical evaluation of the data
  • Ensures control of laboratory documentation (Raw Material COA, testing instructions, testing.
Education:
  • Bachelor's degree in Microbiology, or closely related scientific discipline.
  • Degree in Microbiology is highly preferred.
Experience:
  • Laboratory experience is preferred.
  • Pharmaceutical & FDA/GLP industry experience is preferred over academic laboratory experience.
  • Microbiology laboratory skills and knowledge, such as aseptic techniques, is required.
  • Demonstrated understanding of cGMPs, cGLPs, FDA regulations, and industry guidelines, as well as international regulatory guidelines.
  • Ability to keep neat, accurate and complete records and logs.
  • Must be proactive, results oriented, with a strong attention to detail.
  • Self-starter with good work ethic and ability to work independently with minimum supervision and use good judgment, or as a contributing member of a team.
  • Ability to manage multiple projects simultaneously, meet deadlines, and handle an ever changing, fast paced critical work environment.
  • Strong organizational, analytical, troubleshooting and problem-solving skills.
  • Ability to analyze details and perform structured decision-making on a daily basis.
  • Excellent verbal and written communication.
  • Must be able to read, write, and speak English.
  • Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner.
Physical Requirements:
  • Requires long hours on standing at work bench or in a flow hood.
V2Soft Offers market-competitive wages and excellent benefits. https://www.v2soft.com/careers/benefits
  • Medical, Dental and Vision benefits, which start immediately upon hire.        
  • 401K Retirement Savings Plan
  • 10 Paid Holidays
  • 10 Paid Vacation Days annually
  • Flexible spending
  • Long-term and Short-term disability insurance
  • Life and AD&D insurance
V2Soft is an Equal Opportunity Employer (EOE).