CQV Engineer

biotech; Chicago (IL); On-site; USD 85,000 - 125,000; Full time

Benefits offered by this job

Competitive benefits

Job summary

PSC Biotech is seeking an experienced Validation Engineer to develop, review, and execute commissioning, qualification, and validation documentation for facilities and manufacturing systems in regulated life sciences environments.

You will author IQ/OQ/PQ protocols, support system walkdowns, punch-list resolution, and turnover packages, while coordinating with Engineering, Manufacturing, QA, and Facilities teams. Travel to client sites may be required.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Biotechnology, Chemistry, or related technical discipline.
• Experience supporting commissioning, qualification and validation activities in regulated industries.
• Knowledge of cGMP regulations and industry guidance documents.
• Experience authoring IQ/OQ/PQ protocols and validation reports.
• Familiarity with risk-based validation methodologies and lifecycle approaches.

Responsibilities

• Develop, review, and execute commissioning, qualification, and validation documentation for facilities, utilities, equipment, and manufacturing systems.
• Author and execute IQ, OQ, and PQ protocols.
• Support commissioning activities including system walkdowns, punch-list resolution, turnover packages, and startup support.
• Perform equipment and utility qualification for systems such as HVAC, clean utilities, CIP/SIP, and cleanrooms.
• Support development of validation plans, risk assessments, traceability matrices, and final reports.
• Coordinate with cross-functional stakeholders including Engineering, Manufacturing, Quality Assurance, Automation, and Facilities.

Skills

cGMP knowledge

Technical writing

Cross-functional collaboration

Analytical skills

Problem solving

Travel-ready

Education

Bachelor's degree in Engineering or Life Sciences

Job description

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. Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success. The Experience With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special.

When you decide join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents. We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn. At PSC Biotech®, it’s about more than just a job—it’s about your career and your future.

Your Role

• Develop, review, and execute commissioning, qualification, and validation documentation for facilities, utilities, equipment, and manufacturing systems.
• Author and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
• Support commissioning activities including system walkdowns, punch-list resolution, turnover packages, and startup support.
• Perform equipment and utility qualification activities for systems such as HVAC, clean steam, purified water, WFI, compressed gases, CIP/SIP systems, process equipment, and cleanroom environments.
• Support development of validation plans, risk assessments, traceability matrices, and final reports.
• Participate in discrepancy investigations, deviation resolution, CAPA activities, and change control assessments.
• Coordinate with cross-functional stakeholders including Engineering, Manufacturing, Quality Assurance, Automation, and Facilities.
• Review design documentation, specifications, P&IDs, and engineering packages to ensure qualification readiness.
• Ensure compliance with client procedures, GMP requirements, and applicable regulatory standards.
• Support project planning, scheduling, and execution activities to meet client timelines and deliverables.
• Contribute to continuous improvement initiatives and implementation of risk-based validation approaches.
• Travel to client sites as required to support project execution.

Requirements

• Bachelor's degree in Engineering, Life Sciences, Biotechnology, Chemistry, or a related technical discipline.
• Experience supporting commissioning, qualification, and validation activities within regulated pharmaceutical, biotechnology, medical device, or related industries.
• Working knowledge of cGMP regulations and industry guidance documents.
• Experience authoring and executing IQ/OQ/PQ protocols and validation reports.
• Familiarity with risk-based validation methodologies and lifecycle approaches.
• Experience with manufacturing equipment, process systems, clean utilities, facilities, or cleanroom environments.
• Strong technical writing, documentation, and communication skills.
• Ability to troubleshoot technical issues and collaborate across multidisciplinary teams.
• Strong organizational, analytical, and problem-solving abilities.
• Ability and willingness to travel as required by client projects.
• Must be authorized to work in the U.S. No C2C at this time.

Benefits

Equal Opportunity Employment Statement PSC 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.