Process Validation Engineer

Highly Competitive
  1. Contract
  2. Validation
  3. United States
Raleigh, North Carolina
Posting date: 21 Feb 2019

ProClinical is partnering with a global biotechnology company to advertise a vacancy for a Process Validation Engineer. This organisation is a market leader in innovative medical Devices that aid in the diagnosis and treatment of a variety of diseases, particularly in the oncology field. The Process Validation Engineer will join this company's team in North Carolina.

Due to this company's large-scale validation project, they require the Process Validation Engineer to assist with the pre-project go-live phase. This is a contract phase lasting 6 months, with a high likelihood of extending to 12.

Job Responsibilities:

  • Performing a gap analysis of the company's existing validation protocols and procedures.
  • Identifying shortfalls in existing validation practices as well as areas that require new protocols and procedures to be created.
  • Following the gap analysis, the Process Validation Engineer will write, edit, and execute validation protocols as well as executing re-validation work.

Skills and Requirements:

  • A BA degree.
  • 3-5 years of Validation experience.
  • 3-5 years of Life Sciences experience.
  • A strong process validation background.
  • Demonstrably expert-level writing skills.
  • A proven track record of crafting, drafting, reviewing, and editing validation documents, including SOPs, IQ, OQ, and PQ.
  • Capable of working independently, analysing, working with attention to detail, process and prioritise sensitive complex information, and solve problems.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency in MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Max Kelly on + 312-270-1613 or upload your CV on our website -

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.