CQV Engineer

PSC Biotech•Los Angeles, CA

1d•$100,000 - $120,000

About The Position

We are hiring an experienced CQV engineer responsible for the commissioning, qualification, and validation for facilities, utilities, and equipment in the pharmaceutical and biotech industries. Our engineers play a critical role in driving project success, while supporting validation planning, development, documentation, and execution, and ensuring regulatory standards and quality requirements are met.

Requirements

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.
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 are 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

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.