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PSC Biotech® Corporation · 8 hours ago

Validation Engineer

Columbus, OH

Full-time

Hybrid

Mid Level

PSC Biotech® Corporation provides essential services to the life sciences sector, ensuring compliance with regulatory standards for healthcare products. They are seeking experienced validation engineers to oversee commissioning, qualification, and validation processes for pharmaceutical facilities and equipment, ensuring project success and adherence to regulatory requirements.

BiotechnologyConsultingLife ScienceProject ManagementQuality AssuranceRental

Growth Opportunities

No H1B

Responsibilities

Develop and execute commissioning, qualification, and validation 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 mitigation strategies

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

CommissioningQualificationValidation engineeringRegulatory complianceRisk assessmentTechnical writingAnalytical skillsProblem solvingCommunication skillsProject managementAttention to detail

Required

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

Proven experience in equipment/facility/systems commissioning, qualification, and validation engineering 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

Travel is required. At PSC Biotech, many of our projects and clients are located in various regions around the country. Therefore, we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations, cultures, and work environments is essential, as it allows our team members to collaborate effectively with clients and colleagues nationally

Must be authorized to work in the US

No C2C at this time