The Role
CQV and Validation Engineers support pharmaceutical and biotechnology manufacturing projects through commissioning, qualification, and validation of facilities, utilities, equipment, automation, and processes. Responsibilities include protocol development, field execution, discrepancy resolution, documentation, project coordination, startup support, and audit readiness within GMP environments. Multiple levels are available, from entry-level to senior professionals. Prior Kneat Gx experience is required.
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 and Validation Engineers at multiple experience levels to support pharmaceutical and biotechnology manufacturing projects involving facility, utility, equipment, automation, and process validation activities. These positions will play a key role in commissioning, qualification, and validation efforts associated with manufacturing expansions, new product introductions, capital projects, and operational readiness initiatives within regulated GMP environments.
Successful candidates will contribute to protocol development, field execution, discrepancy resolution, and documentation activities while working closely with engineering, quality, manufacturing, automation, and project teams. Opportunities are available for entry-level through senior-level professionals, with responsibilities scaled according to experience and technical expertise.
Candidates must have prior experience working within Kneat Gx.
Validation Execution & Documentation
- Author, review, execute, and close commissioning, qualification, and validation protocols and reports.
- Support installation, operational, and performance verification activities for facilities, utilities, equipment, and manufacturing systems.
- Execute field testing and document results in accordance with established quality and documentation standards.
- Assist with protocol revisions, data analysis, and final report generation.
- Maintain traceability between requirements, risk assessments, testing activities, and validation deliverables.
Project Support
- Coordinate with project engineers, manufacturing personnel, quality representatives, automation engineers, and vendors during project execution.
- Support project schedules, execution plans, and commissioning readiness activities.
- Participate in project meetings and provide status updates regarding assigned deliverables.
- Assist with turnover, startup, and operational readiness activities.
Quality & Compliance
- Follow approved procedures, validation strategies, standard operating procedures, and Good Documentation Practices (GDP).
- Support investigations, deviations, discrepancies, and corrective action activities.
- Ensure documentation is completed accurately and in a timely manner.
- Contribute to inspection readiness and audit support activities.
Requirements
All Levels:
- Bachelor's degree in Engineering, Biotechnology, Biology, Chemistry, Pharmaceutical Sciences, or a related technical discipline.
- Experience within biopharmaceutical, cell culture, biologics, vaccine, or sterile manufacturing facilities.
- Experience with the digital validation platforms Kneat Gx required.
- Experience supporting one or more of the following:
- Commissioning
- Facility Qualification
- Utility Qualification
- Equipment Qualification
- Cleaning Validation
- Sterilization Validation
- Computerized Systems Validation (CSV)
- Temperature Mapping
- Automation Validation
- Experience with manufacturing execution systems (MES), SCADA, PLC-controlled systems, data integrity programs, or other GMP automation platforms.
- Ability to work in a hybrid environment with onsite support during commissioning, startup, and peak execution periods
Benefits
Equal Opportunity Employment Statement
PSC is committed to 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, Biotechnology, Biology, Chemistry, Pharmaceutical Sciences, or a related technical discipline
- Experience within biopharmaceutical, cell culture, biologics, vaccine, or sterile manufacturing facilities
- Prior experience using the Kneat Gx digital validation platform
- Experience supporting commissioning, facility qualification, utility qualification, equipment qualification, cleaning validation, sterilization validation, computerized systems validation, temperature mapping, or automation validation
- Experience with MES, SCADA, PLC-controlled systems, data integrity programs, or other GMP automation platforms
- Ability to work in a hybrid environment with onsite support during commissioning, startup, and peak execution periods
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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.
