Project Engineer

Job Description

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 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 motivated Project Engineer with direct experience in ensuring adherence to regulatory requirements including EU GMP Annex 1, FDA 21 CRF, and ISO guidelines. This role verifies cleanroom and controlled environment qualifications meet GMP and regulatory standards. This hands-on position requires strong leadership, cross-functional collaboration, and a deep understanding of testing protocols. You’ll be responsible for coordinating and executing testing activities, guiding teams through dynamic room testing, and ensuring all documentation aligns with Annex 1 and internal quality expectations.

• Oversee the planning and execution of room qualification testing, ensuring alignment with production schedules and regulatory requirements.
• Act as a central point of contact between manufacturing, engineering, quality, and external labs to facilitate smooth testing operations.
• Maintain adherence to Annex 1 standards through proper documentation, signage, and procedural controls during testing.
• Create and manage qualification protocols and reports using established templates, ensuring clarity and consistency.
• Identify and respond to deviations during testing, contributing to root cause analysis and corrective actions.
• Apply environmental monitoring systems and particle counting technologies to support data collection and analysis.
• Contribute to facility qualification and requalification efforts, ensuring environments are compliant ahead of audits and inspections
• Additional Responsibilities as assigned.

Requirements

Benefits

Offering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.

Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents

Adhering to the requirements of California's law on salary transparency, the salary bracket for this role is set between $90,000 - $115,000 annually. The salary offered may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.

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.

#LI-RD1