Senior Validation Engineer

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

Job summary

An established industry player is seeking experienced validation engineers to join their dynamic team. This role focuses on the commissioning, qualification, and validation of facilities and equipment in the pharmaceutical and biotech sectors. With a commitment to excellence, the company offers a supportive environment that fosters growth and development. You'll be at the forefront of ensuring compliance with regulatory standards while collaborating with cross-functional teams. If you're passionate about making a difference in the life sciences industry, this opportunity is perfect for you.

Qualifications

• 7+ years of experience in equipment commissioning and validation.
• Strong knowledge of regulatory requirements and industry standards.

Responsibilities

• Develop and execute validation protocols for equipment and systems.
• Ensure compliance with FDA, EMA, and industry standards.
• Collaborate with cross-functional teams to align on activities.

Skills

Regulatory Compliance

Analytical Skills

Technical Writing

Problem-Solving

Project Management

Education

Bachelor’s degree in Engineering

Bachelor’s degree in Life Sciences

Job description

Job Description

PSC Biotech provides the life sciences industry with essential services to ensure that healthcare products are developed, manufactured, and distributed according to the highest standards and regulatory requirements.

Our goal is to accelerate our clients’ success. We employ a global team of skilled professionals across North America, Europe, Asia, and the Middle East, and are proud of the roles we have fulfilled to help our clients achieve success.

The Experience

With operations worldwide and a multicultural team, PSC Biotech is passionate about bringing together the best and brightest. Joining our team offers opportunities to be inspired, explore your passions, and work with a group that values and nurtures your talents.

We believe in coaching and developing future industry leaders. We offer competitive compensation and benefits, along with tools to support your growth and learning.

At PSC Biotech, it’s about more than just a job—it’s about your career and future.

Your Role

This is a W2-temp role for 6 months with the potential for FTE extension. We seek experienced validation engineers responsible for commissioning, qualification, and validation of facilities, utilities, and equipment in the pharmaceutical and biotech industries. Your role is critical in ensuring project success through validation planning, documentation, execution, and compliance with regulatory standards.

• Develop and execute commissioning, qualification, and validation protocols for equipment and systems.
• Prepare and maintain validation documentation, including protocols, reports, and SOPs.
• Support tech transfers to bring new processes to client sites.
• Complete validation documentation and execution for manufacturing equipment and analytical instruments.
• Identify risks in CQV activities and develop mitigation strategies.
• Troubleshoot and resolve equipment and process issues.
• Collaborate with cross-functional teams to align on activities and timelines.
• Ensure compliance with FDA, EMA, and industry standards like GMP and GAMP.
• Perform additional duties as needed to ensure project success.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 7+ years of experience in equipment commissioning, qualification, and validation in pharma/biotech industries.
• Strong knowledge of regulatory requirements and industry standards.
• Experience with validation lifecycle management and risk-based approaches.
• Excellent analytical, technical, and problem-solving skills.
• Proficient in technical writing and full lifecycle documentation.
• Effective communication and interpersonal skills.
• Proactive, organized, and capable of managing multiple projects.
• Attention to detail, quality, and compliance.
• Willing and able to travel as needed for project assignments, with adaptability to different locations and cultures.

PSC is an Equal Opportunity Employer. We comply with all applicable laws regarding employment discrimination and prohibit discrimination based on protected statuses.