Validation Engineer
5 months ago
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 skilled and experienced Validation Engineer to join our team.
- Develop, execute, and document validation protocols and reports for terminal sterilization processes.
- Design, develop, and optimize terminal sterilization cycles for pharmaceutical products.
- Conduct feasibility studies and experimental runs to determine optimal cycle parameters.
- Analyze and interpret data to ensure cycle consistency, reliability, and effectiveness.
- Develop and execute process qualification protocols (IQ, OQ, PQ) for terminal sterilizers.
- Prepare detailed validation protocols, reports, and standard operating procedures (SOPs).
- Ensure compliance with FDA, EMA, and other relevant regulatory bodies’ guidelines and standards.
- Work closely with manufacturing, quality assurance, R&D, and other departments to support validation activities.
- Additional responsibilities as required.
Requirements
- 8-15 years of experience in Validation Engineering in a pharmaceutical manufacturing environment.
- Strong knowledge of terminal sterilization processes, cycle development, performance qualification and process qualification.
- Familiarity with regulatory requirements (FDA, EMA, GMP) and industry standards (ISO 11135, ISO 14937).
- Strong technical writing and documentation skills.
- Ability to work independently and collaboratively in a team environment.
- At PSC Biotech, many of our projects and clients are located in various regions around the country. Therefore, we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations, cultures, and work environments is essential, as it allows our team members to collaborate effectively with clients and colleagues nationally.
BenefitsOffering 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 dependentsInsurance 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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