Join the ValSource Team
ValSource is one of the largest independent Validation Services Company in North America with over 350 full-time Engineering, Commissioning, Qualification, and Validation employees. We return validation to a scientific event that helps companies design, perform, and better control manufacturing processes throughout all stages of the operations life cycle.
Culture & Values
We are experts in navigating regulated industries and the rigorous requirements that accompany them. Since 1996 our 350-strong talent force has proudly served our clients as advisors, trusted consultants, and highly experienced program managers.
Full-time employees are offered a competitive compensation package that also includes full benefits (medical, dental, vision, short- and long-term disability premiums 100% paid by ValSource), Life insurance, 401k, paid time off (holidays and vacation), continuous training and development, Employee Stock Ownership Plan, discretionary bonus, etc.
Join the ValSource Team.
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.
We seek Quality Risk Management thought leaders. We demand exceptionally skilled, intellectually energetic professionals.
The bigger question: What do you seek?
Our mindset is lead. Innovate. Our skillset is the industries’ most formidable.
Our clients are the names you know best. Your fellow consultants, 250-strong, include mechanical engineers, electrical engineers, computer engineers, computer scientists, chemical engineers, chemists, statisticians, life scientists and microbiologists. We serve in positions of consequence, shaping the future of our work and its impact on society.
You consult, providing consequential expertise on the design, implementation, usability, training and effectiveness of clients’ Quality Risk Management programs. Complex knowledge of the manufacturing processes and product, process and equipment lifecycle management, as well as Quality Management Systems is a must.
This is a full-time consulting position. You’ll propel a variety of Quality Risk Management and Quality Systems projects.
Validation (CQV) Engineer
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.
The 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 editing 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.
* Experience with cleaning validation, process and utility systems validation, laboratory systems & equipment, temperature mapping, manufacturing equipment qualification & validation, etc.
* Generation, and supporting the troubleshooting and closeout 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 the project.
The project leader may be responsible for both direct execution and supervision of field activities.
* 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, Excel, and PowerPoint. Microsoft Project and Visio a plus.
*Two (2) to five (5) or more years of Commissioning, Qualification and Validation (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.
* 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.