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Validation Engineer

Summary

ValSource is looking to hire and train Commissioning, Qualification and Validation (CQV) Engineer’s in our regions across the United States.  As a full-time ValSource employee you will support our project teams with commissioning, qualification, validation, and process engineering projects at various client sites in each region.

 

Responsibilities

Individuals will be trained to generate and execute validation protocols for the project start-up, the Commissioning, Qualification, Validation (CQV) of Pharmaceutical and Biotech GMP manufacturing equipment, critical and non-critical utilities, cleaning systems/processes, automation systems and lab equipment. Projects may include the following scope(s) of work:

  • Risk Assessments, Impact assessments establishment of systems boundaries.
  • Generation, Review, and editing of Standard Operating Procedures (SOP’s).
  • Review and verification of ETOP’s (Engineering Turn Over Packages).
  • Generation and execution of protocols for Design Qualifications (DQ), Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Verification (IV), Operation Verification (OV), Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (OQ).
  • Cleaning and sterilization validation of manufacturing equipment.
  • Temperature mapping.
  • Generation and support for troubleshooting and close out of discrepancies and deviations.

 

Education

BS Degree in Engineering/ STEM discipline or related technical degree. Related experience in the Engineering and pharmaceutical/Biotech fields will be considered.

 

Requirements

Strong organizational skills, excellent writing, and communications skills. Must be able to work in a team environment, interacting with individuals at all levels in an organization and departmental areas.

 

Experience

  • Recent graduate - Two (2) years’ experience.
  • BS Degree in Engineering or Science

 

Travel Potential

It is our goal to assign people to projects that are within a commutable distance from their home. This allows ValSource to be more cost competitive, save money for our clients and minimizes the travel burden on our employees. While we will try to adhere to this philosophy, you may be required to travel for a portion of your projects. Expenses incurred for travel related assignments will be reimbursed in accordance with our travel policy.

 

About ValSource

ValSource is one of the largest independent validation services companies in North America with over 350 full time Engineering, Commissioning, Qualification and Validation employees. ValSource returns validation to a scientific event which helps companies design, perform and better control manufacturing processes throughout all stages of the operations life cycle. Full-time employees are offered a competitive compensation package that also includes full benefits (100% employer paid medical, dental, vision, short- and long-term disability), 401k, paid time off (holidays and vacation), continuous training and development, Employee Stock Ownership Plan (ESOP), discretionary bonus, etc.

 

Authorization

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States up hiring/onboarding.  ValSource participates in E-Verify and will provide the Federal Government with your Form I-9 information to confirm that you are authorized to work in the United States. 

 

Equal Employment Opportunity:

ValSource provides equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, genetic information, military, and veteran status.