Process Validation Engineer

Highly Competitive
  1. Permanent
  2. Validation
  3. United States
Warsaw, Indiana
Posting date: 21 Feb 2019

ProClinical are partnering with a leading workforce management solution company to advertise a vacancy for a Process Validation Engineer. This organisation, which specialises in multiple scientific and engineering sectors, is seeking a new team member for their office in Indiana. This is an excellent opportunity for a practised Validation Engineer to join a prestigious company and deliver expertise.

Job Responsibilities:

  • Executing Process Validations under the guidance of Process Engineering Team Lean & Manager.
  • Processing manual and automated inspections.
  • Reviewing scrap data to determine root cause and corrective actions for areas of responsibility.
  • Leading teams on annual reviews of validation and verification processes.
  • Providing direct team support and training as needed.
  • Improving lead-times, cycle-times, and costs of conversion for assigned areas.
  • Drafting/maintaining Validation Plans and strategies, along with protocols; collaborating feedback with approvers.

Skills and Requirements:

  • A degree in an Engineering field.
  • Lean training and certification.
  • 2-6 years of experience in a GMP industry, preferably executing Validations, developing processes, continuous improvement, and annual process reviews.
  • Demonstrable experience with Gage R&R, Process variation reduction, and CNC processes.
  • Experience with Software Validation and Vision system programming and validation.
  • Experience with CNC programming, laser etch programming, and vision system programming.
  • Experience with packaging & cleaning.
  • Experience with PM development and review for maintaining validated or verified processes.
  • Experience with Minitab preferred.
  • Experience with CAPA.
  • A thorough understanding of process capability and root cause analysis.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, persuasion, influence, and leadership.
  • 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 Mary Jacobs on + 267-477-4800 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.