CQV Engineer

About the Company

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, employing a global team of skilled professionals and experts across strategically located offices in North America, Europe, Asia, and the Middle East. We are passionate about bringing the best and brightest together to form something truly special, offering a multicultural and inspiring work environment.

At PSC Biotech, it’s about more than just a job—it’s about your career and your future. We are firm believers in coaching and developing the next generation of industry leaders and influencers, providing tools for growth and learning alongside a competitive compensation and benefits structure.

About the Role

We are hiring experienced validation engineers responsible for the commissioning, qualification, and validation (CQV) of facilities, utilities, and equipment in the pharmaceutical and biotech industries. Our engineers play a critical role in driving project success by supporting validation planning, development, documentation, and execution while ensuring regulatory standards and quality requirements are met.

Responsibilities

• Develop and execute commissioning, qualification, and validation protocols for production-scale process equipment and systems, including Mix Vessels, Cents, Filter Presses, and others.
• Prepare and maintain comprehensive documentation, including validation protocols, plans, reports, and standard operating procedures.
• Identify and assess risks associated with CQV activities and develop effective mitigation strategies.
• Troubleshoot and resolve issues related to equipment and process performance.
• Collaborate 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.
• 2-7 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).
• Effective communication and interpersonal skills.
• Proactive with strong organization, time management, and project management abilities.
• Excellent attention to detail with a commitment to quality and compliance.
• Flexibility to work evenings and weekends when required.
• Willingness and ability to travel as needed for project assignments and client engagements.
• Must be authorized to work in the U.S. (No C2C at this time).

Benefits

• Medical, Dental, and Vision: PSC pays 100% of qualifying employee medical premiums and 50% for qualifying dependents.
• Insurance options for Employee Assistance Programs, Basic Life Insurance, and Long-Term Disability.
• 401(k) with company matching.
• Paid Time Off (PTO), Sick Time, and Paid Holidays.
• Education Assistance.
• Pet Insurance.
• Discounted rate at Anytime Fitness.
• Financial Perks and Discounts.

Pay

The salary bracket for this role is $85,000 - $100,000 annually. The salary offered may be adjusted based on the applicant’s qualifications, skills, and professional experience.