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PSC Biotech® Corporation · 1 day ago

CQV Engineer

Ventura County, CA

Full-time

Onsite

Senior Level

$100K/yr - $120K/yr

6+ years exp

PSC Biotech® Corporation provides essential services to the life sciences sector, ensuring compliance with regulatory standards for healthcare products. The CQV Engineer will be responsible for the commissioning, qualification, and validation of facilities and equipment in the pharmaceutical and biotech industries, ensuring project success and regulatory compliance.

BiotechnologyConsultingLife ScienceProject ManagementQuality AssuranceRental

Growth Opportunities

No H1B

Responsibilities

Develop and execute commissioning, qualification, and validation protocols for required systems and equipment (i.e process skids, chromatography skids)

Prepare and maintain comprehensive documentation, including validation protocols, plans, reports, and standard operating procedures

Identify and assess risks associated with CQV activities and develop effective mitigation strategies

Troubleshoot and resolve issues related to equipment and process performance

Collaborative with cross-functional teams to ensure alignment on CQV activities and project timelines

Ensure compliance with regulatory requirements (FDA, EMA, etc.) and industry standards (GMP, GAMP, etc.)

Additional responsibilities as required to drive successful validation project deliverables

Qualification

CQV engineeringRegulatory complianceValidation protocolsRisk assessmentTechnical writingAnalytical skillsCommunication skillsProject managementAttention to detail

Required

Bachelor's degree in Engineering, Life Sciences, or a related field

6-10 years of equipment commissioning, qualification, and validation engineering experience in the pharmaceutical and/or biotech industries

Strong knowledge of regulatory requirements and industry standards

Experience with validation lifecycle management and risk-based approaches

Excellent analytical and technical problem solving skills

Strong technical writing skills and understanding of full lifecycle documentation (protocols, reports, procedures, risk assessments, specifications and requirements, etc.)

Effective communication and interpersonal skills

Proactive with strong organization, time management, and project management abilities

Excellent attention to detail with commitment to quality and compliance

Willing and able to travel as needed for project assignments and client engagements

Must be authorized to work in the US