Senior Validation Engineer

PSC Biotech; Durham (NC); On-site; USD 80,000 - 110,000; Full time

Job summary

Join a forward-thinking company that is dedicated to ensuring the highest standards in the life sciences sector. As a validation engineer, you'll play a pivotal role in the commissioning and validation processes that are critical for success in the pharmaceutical and biotech industries. This temporary role offers the chance to work with a diverse team of professionals, where your skills in technical writing, analytical problem solving, and project management will be highly valued. With opportunities for growth and learning, this position is not just a job—it's a step towards a rewarding career in a dynamic environment.

Qualifications

• 7+ years of experience in validation engineering in pharma/biotech.
• Strong knowledge of regulatory requirements and industry standards.

Responsibilities

• Develop and execute validation protocols for equipment and systems.
• Ensure compliance with regulatory requirements and industry standards.

Skills

Analytical Skills

Technical Writing

Problem Solving

Project Management

Communication Skills

Education

Bachelor's degree in Engineering

Bachelor's degree in Life Sciences

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

This is a W2-Temp 6-month role with potential FTE extension. We are hiring experienced validation engineers responsible for the commissioning, qualification, and validation for facilities, utilities, and equipment in the pharmaceutical and biotech industries. Our engineers play a critical role in driving project success, while supporting validation planning, development, documentation, and execution, and ensuring regulatory standards and quality requirements are met.

• Develop and execute commissioning, qualification, and validation protocols for required equipment and systems.
• Prepare and maintain comprehensive documentation, including validation protocols, plans, reports, and standard operating procedures.
• Support tech transfers to bring new processes to client sites.
• Complete validation documentation and execution on manufacturing process equipment and analytical instrumentation.
• Identify and assess risks associated with CQV activities and develop effective mitigation strategies.
• Troubleshoot and resolve issues related to equipment and process performance.
• Collaborative with cross-functional teams to ensure alignment on CQV activities and project timelines.
• Ensure compliance with regulatory requirements (FDA, EMA, etc.) and industry standards (GMP, GAMP, etc.).
• Additional responsibilities as required to drive successful validation project deliverables.

Requirements

• Bachelor's degree in Engineering, Life Sciences, or a related field.
• 7+ years of equipment commissioning, qualification, and validation engineering experience in the pharmaceutical and / or biotech industries.
• Strong knowledge of regulatory requirements and industry standards.
• Experience with validation lifecycle management and risk-based approaches.
• Excellent analytical and technical problem solving skills.
• Strong technical writing skills and understanding of full lifecycle documentation (protocols, reports, procedures, risk assessments, specifications and requirements, etc.)
• Effective communication and interpersonal skills.
• Proactive with strong organization, time management, and project management abilities.
• Excellent attention to detail with commitment to quality and compliance.
• 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.

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.