Careers

Positions
Validation (CQV) Engineers / Project Leads / Project Managers

ValSource is one of the largest independent Validation Services Company in North America with over 200 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 (medical, dental, vision, short- and long-term disability), 401k, paid time off (holidays and vacation), continuous training and development, Employee Stock Ownership Plan, discretionary bonus, etc.

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.

Summary

ValSource is currently looking to identify several Validation Engineer candidates on a full-time basis to support a variety of different commissioning, qualification, validation and process engineering related projects with our clients throughout each of our regions in the U.S.

Responsibilities

Individual will be responsible for activities related to the start-up, commissioning, qualification, validation of Pharmaceutical and Biotech GMP manufacturing facility systems and equipment.  Responsibilities are expected to include but are not limited to:

  • Collaboratively conduct Risk Assessments and Impact assessments, and establish system boundaries
  • Generation, Review, and edition of Standard Operating Procedures.  Review and verification of ETOP’s.
  • Generation and execution of protocols for DQ, FAT, SAT, IV OV, IQ, OQ, and PQ.
  • Experience with the cleaning and sterilization validation of manufacturing equipment
  • Generation, and supporting the troubleshooting and close out of discrepancies and deviations

Systems and equipment to be addressed will include manufacturing equipment, critical and non-critical utilities, cleaning systems/processes, automation systems and lab equipment.

Additional duties may include attendance at client meetings, preparation of project budgets, review of invoices, and any other duties as required to control financial and execution related aspects of project.

Project leader may be responsible for both direct execution and supervision of field activities.

Requirements
  • Strong organizational skills, excellent writing and communications skills.  Must be able to work independently and in a team environment, interacting with individuals at all levels in an organization and departmental areas.
  • Ability to be flexible to address both shifting priorities and changes in approach in dynamic work environments.
  • Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for validation of GMP facilities.
  • Proficiency with Microsoft office including Word, Excell, and PowerPoint.  Microsoft Project and Visio a plus.
Experience

Two (2) to five (5) or more years of CQV experience in Pharmaceutical, Biotech, Medical Device or related GMP manufacturing environment preferred.

Prior practical experience at a GMP facility in a Process Engineering, Facilities or Operations role with skills that transfer to CQV duties also considered.

Education

Four-year college degree in engineering or science related curriculum required

Due to the full-time nature of these opportunities with ValSource, employment agencies or independent contractors need not respond.

Other Information

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.