The Role
Supports commissioning, qualification, and validation of pharmaceutical and biotechnology facilities, utilities, equipment, and manufacturing systems. Develops and executes IQ/OQ/PQ protocols, validation plans, risk assessments, traceability matrices, and reports. Performs system walkdowns, investigates discrepancies, supports CAPA and change controls, and coordinates with engineering, manufacturing, quality, automation, and facilities teams to ensure cGMP compliance. Travel to client sites is required as needed.
Summary Generated by Built In
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
We are seeking CQV Engineers of varying experience levels to support commissioning, qualification, and validation activities for facilities, utilities, equipment, and manufacturing systems within regulated life sciences environments. The CQV Engineer will play a critical role in ensuring systems are designed, installed, tested, and operated in compliance with cGMP requirements, industry standards, and client expectations.
Successful candidates will collaborate with engineering, quality, manufacturing, and project teams to deliver compliant and efficient validation solutions.
- 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.
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Skills Required
- Bachelor's degree in Engineering, Life Sciences, Biotechnology, Chemistry, or a related technical discipline
- Experience supporting commissioning, qualification, and validation activities in pharmaceutical, biotechnology, medical device, or related regulated 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
- Authorization to work in the United States
- No C2C arrangements
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The Company
What We Do
Founded in 1996, PSC Biotech Corporation was created with the vision of providing life science companies unmatched support. To date, PSC Biotech Corporation now serves 1000 clients in more than 35 countries worldwide through professional services consulting, cloud-based software solutions, pharmaceuticals contract manufacturing, life science investment consulting, and metrology services. PSC Biotech Corporation has six unique divisions within the parent company – each representing one of our areas of expertise: PSC Biotech, PSC Software, BioTechnique™, PSC Partners, PSC Metrology and PSC Investments. Additionally, PSC Asia and PSC Biotech Ltd represent PSC Biotech Corporation in Asia and Europe, respectively. Together, these divisions enable us to meet the ever-changing needs of our clients with a commitment to excellence and superior quality.
