CQV Engineer

biotech; Los Angeles (CA); On-site; USD 85,000 - 100,000; Full time

Benefits offered by this job

Medical, Dental, and Vision

401(k) with employer matching

PTO and holidays

Education Assistance

Pet Insurance

Discounted gym memberships

Job summary

PSC Biotech in California is seeking a CQV Engineer to develop and execute commissioning, qualification, and validation protocols for production scale equipment and systems, including Mix Vessels and Filter Presses.

You will prepare comprehensive documentation, assess risks, troubleshoot issues, and collaborate with cross-functional teams to meet project timelines while ensuring GMP, GAMP, and FDA/ EMA regulatory compliance. Some travel and occasional weekend hours may be required.

Qualifications

• 2–7 years of equipment commissioning, qualification, and validation experience in pharma/biotech.
• Strong knowledge of regulatory requirements and industry standards.
• Experience with validation lifecycle management and risk-based approaches.

Responsibilities

• Develop and execute commissioning, qualification, and validation protocols for production scale equipment and systems.
• Prepare and maintain validation plans, protocols, reports, and SOPs.
• Identify and mitigate risks associated with CQV activities.
• Troubleshoot equipment and process performance issues.
• Collaborate with cross-functional teams to align on CQV activities and timelines.
• Ensure compliance with FDA, EMA, GMP, and GAMP standards.

Skills

CQV experience

Regulatory knowledge

Documentation writing

Analytical problem solving

Communication skills

Project management

Education

Bachelor’s degree in Engineering

Job description

Responsibilities

• Develop and execute commissioning, qualification, and validation protocols for required production scale process equipment and systems including Mix Vessels, Cents, Filter Presses, etc.
• 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.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• 2–7 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.

Additional Requirements

• Flexibility to work evenings and weekends when required.
• Willingness and ability to travel for project assignments and client engagements.
• Ability to adapt to different locations, cultures, and work environments.
• Authorized to work in the U.S. (must be a U.S. citizen or legal permanent resident; no C2C arrangements).

Salary

Adhering to the requirements of California’s law on salary transparency, the salary bracket for this role is set between $85,000–$100,000 annually. The salary offered may be adjusted based on various factors such as the applicant’s qualifications, skills, and professional experience.

Benefits

• Medical, Dental, and Vision – PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents.
• Employee Assistance Programs, Basic Life Insurance, Long Term Disability.
• 401(k) with employer matching.
• PTO, Sick Time, and Paid Holidays.
• Education Assistance.
• Pet Insurance.
• Discounted rate at Anytime Fitness.
• Financial Perks and Discounts.

Equal Opportunity Employment Statement

PSC Biotech is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. 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, sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.