CQV Engineer

CQV Engineer / PSC Biotech® Corporation

Join us as a CQV Engineer responsible for the commissioning, qualification, and validation of facilities, utilities, and equipment in the pharmaceutical and biotech industries. This role supports validation planning, documentation, and execution while ensuring regulatory compliance.

• Develop and execute commissioning, qualification, and validation protocols for required systems and equipment (e.g., 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.
• 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.).
• Perform additional responsibilities as required to drive successful validation project deliverables.

• 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.
• Willingness to travel as needed for project assignments and client engagements.
• Must be authorized to work in the U.S.
• No C2C at this time.

W2 temporary positions include medical and sick time benefits.

Salary: $100,000–$120,000 annually, adjustable based on qualifications, skills, and experience.

PSC is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. PSC prohibits discrimination against qualified employees, interns, and applicants in all aspects of employment, including recruitment, interviewing, hiring, evaluation, compensation, promotion, and all other employment decisions. This policy complies with all applicable federal, state, and local laws concerning employment discrimination.

• Mid‑Senior level

• Full‑time

• Engineering and Information Technology

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