CQV Engineers (Multiple Levels)
About The Position
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. 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.
Requirements
- 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
Responsibilities
- 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.
- 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.
- 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.
Benefits
- Equal Opportunity Employment Statement
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
