CQV Engineer

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 make the decision to 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 hiring a CQV Engineer to support projects within the pharmaceutical, biotechnology, and medical device industries. This is a remote position responsible for supporting commissioning, qualification, and validation (CQV) activities to ensure systems, equipment, and facilities meet regulatory requirements and project objectives.

The CQV Engineer will support the execution of validation and commissioning activities across multiple projects while collaborating with internal teams and clients to ensure timely and compliant project delivery. The incumbent is also responsible and accountable for executing the PSC mission: “to maintain the integrity and professionalism of our products and services while enabling steady growth and development.”

This role will support the Australian team and is expected to work Australian business hours from 8:00 AM to 5:00 PM AEST.

• Support the execution of multiple validation and CQV projects, ensuring successful delivery of commissioning, qualification, and validation activities.
• Support multiple workstreams projects while providing updates to stakeholders and clients.
• Support the development, execution, and review of validation protocols and documentation, including DQ, FAT, SAT, IQ, OQ, PQ, and PV.
• Assist in commissioning, qualification, and validation of facilities, utilities, equipment, and systems within regulated environments.
• Ensure projects align with regulatory requirements, cGMP standards, and industry’s best practices.
• Coordinate risk assessments, design reviews, and project planning activities.
• Collaborate with internal teams, contractors, and vendors to support project deliverables.
• Present project progress, risks, and outcomes to clients and internal leadership teams.
• Make effective decisions when managing competing priorities or project challenges.
• Ensure proper documentation, reporting, and compliance with GMP and GDP standards.
• Additional duties and responsibilities may be assigned from time to time.