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PSC Biotech® Corporation · 2 weeks ago

CQV Engineer

Durham, NC

Full-time

Hybrid

Entry, Mid, Senior Level

PSC Biotech® Corporation provides essential services to the life sciences sector, ensuring compliance with regulatory requirements for healthcare products. The CQV Engineer will be responsible for commissioning, qualification, and validation activities in the pharmaceutical and biotech industries, playing a key role in project success and regulatory compliance.

BiotechnologyConsultingLife ScienceProject ManagementQuality AssuranceRental

Growth Opportunities

No H1B

Responsibilities

Develop, write, and execute IQ, OQ, PQ protocols for required equipment and systems

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

Support deviation resolution, change control assessments, and CAPA activities

Troubleshoot and resolve issues related to equipment and process performance

Collaborate 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 complianceRisk-based validationAnalytical problem solvingTechnical writingProject managementEffective communicationAttention to detailOrganizational skillsInterpersonal skills

Required

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

Proven experience in equipment commissioning, qualification, and validation engineering experience in the pharmaceutical manufacturing industry

Strong knowledge of regulatory requirements and industry standards

Strong understanding of risk-based validation and full life cycle approach

Experience qualifying large process equipment and supporting utilities (i.e. vessels, CIP/SIP skids, isolators, autoclaves, WFI, clean steam, etc.)

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

No C2C at this time