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.

Responsibilities
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.

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, Excel, and PowerPoint. Microsoft Project and Visio a plus.
Experience

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.
Equal Employment Opportunity

ValSource is an equal opportunity employer. We provide 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 status, or veteran status. We are committed to creating an inclusive environment for all employees.

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.

Other Information

These career opportunities are full-time positions with ValSource. Applicants must be authorized to work in the United States on a full-time basis without the need for current or future sponsorship. We do not accept unsolicited applications or resumes from third-party staffing agencies, independent contractors, or recruiting vendors.

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.