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Validation Engineer
Ref No.: 18-00735
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:
  • Conduct method development, method validation and method transfer for cleaning residual methods
  • Experience with cleaning agent HPLC method development and validation
  • Knowledge with swab coupon recovery studies
  • Excellent oral and written communication skills for participating in problem-solving teams and customer visits, as necessary.
  • Ability to work within given deadlines as required.
  • Know commonly used analytical equipment, its function and operation. Such equipment includes HPLC, UV-Vis and IR spectrophotometers, gas chromatograph, liquid chromatograph, incubator, oven, analytical scale, centrifuge, etc.
  • Maintain a chemically hygienic working environment.
Education:

• Bachelor's degree in Life Sciences, or closely related scientific discipline.
• Degree in Chemistry is highly preferred.

Experience:
  • Previous experience in writing and executing Method Validation protocols and reports.
  • 2-7 years of experience in Method Development in a GMP Pharmaceutical Industry Quality Control Laboratory a must.
  • Familiar with GMP regulated industry.
  • Expert with HPLC (UV/PDA/DAD detector)
  • Proficient in Empower software,
  • Knowledgeable in Microsoft Word and Excel
  • 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 analyses details and perform structured decision-making daily.
  • 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).