Job Description Your RoleWe are hiring an experienced CQV Engineer to join our team! CQV Engineers are responsible for thecommissioning,qualification, and validation for facilities,utilities, andequipment in the pharmaceutical and biotechindustries. Ourengineers play a critical role in drivingproject success, whilesupporting validation planning,development, documentation, andexecution, and ensuringregulatory standards and qualityrequirements are met.
- Develop and executecommissioning, qualification, and validation protocols forrequired equipment and systems.
- Prepare andmaintaincomprehensive documentation, includingvalidation protocols, plans, reports, and standardoperating procedures.
- Identify and assessrisks associated with CQV activities and develop effectivemitigation strategies.
- Troubleshoot andresolve issues related to equipment and processperformance.
- Collaborative withcross-functional teams to ensure alignment on CQV activitiesand project timelines.
- Ensure compliancewith regulatory requirements (FDA, EMA, etc.) and industrystandards (GMP, GAMP, etc.).
- Additionalresponsibilities as required to drive successful validationproject deliverables.
Requirements- Bachelor's degreeinEngineering, Life Sciences, or a related field.
- 5 years minimum ofequipment commissioning, qualification, and validationengineering experience in the pharmaceutical and/or biotechindustries.
- Strong knowledge ofregulatory requirements and industry standards.
- Experience withvalidation lifecycle management and risk-basedapproaches.
- Excellentanalyticaland technical problem solvingskills.
- Strong technicalwriting skills and understanding of full lifecycledocumentation (protocols, reports, procedures, riskassessments, specifications and requirements, etc.)
- Effectivecommunication and interpersonal skills.
- Proactive withstrongorganization, time management, and projectmanagement abilities.
- Excellent attentionto detail with commitment to quality and compliance.
- At PSC Biotech,manyof our projects and clients are located invarious regionsaround the country. Therefore, wevalue candidates who arewilling and able to travelas needed for project assignmentsand clientengagements. The ability to adapt to differentlocations, cultures, and work environments are essential, asitallows our team members to collaborateeffectively withclients and colleagues nationally.
- Must be authorized towork in the US.
- No C2C at this time.
Benefits 
