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Validation (CQV) Engineer – Commissioning, Qualification, Validation, and Process Engineering

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.