Senior Validation Engineer
Job Posting for Senior Validation Engineer at PSC Biotech
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 Senior Validation Engineer to support a new GMP manufacturing facility build out. The Senior Validation Engineer will play a crucial role in the commissioning, qualification, and validation activities of utilities systems and room qualifications. As a key member of our engineering team, you will be responsible for ensuring that all processes and systems meet regulatory requirements, industry standards, and internal quality standards. The successful candidate will have a deep understanding of commissioning, qualification, and validation processes, as well as the ability to lead cross-functional teams to achieve project goals.
- Lead the development and execution of commissioning, qualification, and validation protocols and drive succesful project completion.
- Collaborate with cross-functional teams to ensure alignment of CQV activities with project timelines.
- Execute IQ, OQ, and PQ, protocols for utilities systems (including compressed air systems, vacuum systems, etc.) and room qualifications. Ensure that equipment and systems meet specifications and regulatory requirements/compliance.
- Execute IOQ for analytical instrumentation and process equipment, including bioreactors, incubators, liquid nitrogen tanks, freezers, etc.
- Perform risk assessments and develop strategies to mitigate risks associated with commissioning, qualification, and validation activities.
- Provide technical expertise in troubleshooting and resolving issues related to equipment, processes, and systems during commissioning and qualification.
- Review and approve documentation related to CQV activities, including protocols, reports, and standard operating procedures (SOPs).
- Identify opportunities for process improvement in commissioning, qualification, and validation activities.
- Implement best practices to enhance efficiency and effectiveness. Ensure compliance with regulatory requirements, industry standards, and company policies throughout the CQV process.
- Mentor and train junior CQV engineers, fostering a culture of continuous improvement and knowledge sharing.
- Additional responsibilities as required.
Requirements
- Bachelor's Degree in Engineering or related.
- 10 years of commissioning, qualification, and validation experience in the pharmaceutical manufacturing industry.
- In-depth knowledge of regulatory requirements, including FDA, EMA, and other relevant authorities.
- Proven experience leading CQV activities for complex projects or systems.
- Experience and strong knowledge of various process equipment. Experience with bioreactors, incubators, liquid nitrogen tanks, freezers, etc.
- Experience and knowledge of utilities systems (compressed air systems, vacuum systems, etc.)
- Experience with room qualifications.
- Strong analytical and problem-solving skills, with the ability to make data-driven decisions.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
- Detail-oriented with strong organizational abilities.
- Highly motivated with the ability to work independently, manage multiple projects, and meet deadlines.
- Travel is required. 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.
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
- Discounted rate at Anytime Fitness
- 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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