Autoclave Validation Engineer

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 ExperienceWith 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 seeking a highly experienced Autoclave Validation Engineer with focused experience in Steam Sterilization, particularly Autoclave or SIP (Sterilize-in-Place) Validation. This role is critical in supporting the qualification and validation of sterilization systems used in pharmaceutical manufacturing. You will lead the planning, execution, and documentation of autoclave validation efforts to ensure all processes meet current regulatory, quality, and operational standards. Key Responsibilities :

• Develop and execute protocols for autoclave and SIP validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Document validation lifecycle deliverables, including protocols, reports, and standard operating procedures (SOPs).
• Identify risks and provide mitigation strategies during steam sterilization validation activities.
• Analyze thermal mapping data, troubleshoot cycle failures, and optimize sterilization performance.
• Collaborate with QA, Manufacturing, and Engineering teams to ensure timely and compliant validation activities.
• Maintain adherence to GMP, FDA, EMA, and industry-specific validation standards.
• Provide support for audits, inspections, and technical documentation related to autoclave and SIP systems.
• Perform additional validation tasks to support successful project outcomes, as needed.

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.

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-JD1