CQV Engineer

Columbus, United States

PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.

We are hiring an experienced CQV Engineer to join our team! CQV Engineers are 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.

• 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 effective 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.

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• 5 years minimum 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.
• Willingness to travel as needed for project assignments and client engagements.
• Must be authorized to work in the US.
• No C2C at this time.

PSC Biotech is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs.

Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.