Autoclave Validation Engineer
Autoclave Validation Engineer
Posted on :
05-06-2025
Employer Active
1 Vacancy
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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 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
- Bachelor s degree in Engineering Life Sciences or a related field.
- 5 7 years of hands-on experience specifically in autoclave or SIP validation within a pharmaceutical or biotech environment.
- Strong understanding of steam sterilization science industry standards (e.g. ISO 17665 PDA Technical Reports) and regulatory requirements (e.g. FDA EMA).
- Experience in validation planning thermal mapping and lifecycle documentation.
- Proficiency in troubleshooting equipment/process issues during validation.
- Excellent communication documentation and organizational skills.
- Detail-oriented with a strong commitment to quality and regulatory compliance.
- Willingness to travel to client sites as project needs arise.
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
- Insurance options for Employee Assistance Programs Basic Life Insurance Short/Long Term Disability and more.
- 401(k) and 401(k) matching
- PTO Sick Time and Paid Holidays
- Education Assistance
- Pet Insurance
- Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness 24-Hour Fitness and more).
- Financial Perks and Discounts
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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Autoclave Validation Engineer
Employment Type
Full Time
Key Skills
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