CQV Engineer

San Juan, PR
Permanent
Full-time

10 days ago

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 ExperienceWith 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 RoleWe are hiring experienced validation engineers responsible for the commissioning, qualification, and validation of facilities, utilities, and equipment, including sterile fill‑finish operations. This role supports isolator systems and aseptic filling line validation, while contributing to validation planning, documentation, execution, and overall project success to ensure compliance with regulatory standards and quality requirements.

Develop and execute commissioning, qualification, and validation protocols for facilities, utilities, and equipment, including sterile fill‑finish systems, isolators, and aseptic filling lines.

Prepare and maintain comprehensive validation documentation, including protocols, plans, reports, and standard operating procedures.

Identify and assess risks associated with CQV activities and implement effective mitigation strategies.

Troubleshoot and resolve issues related to equipment, isolator, and filling line performance.

Collaborate with cross‑functional teams to ensure alignment on CQV activities, sterile manufacturing requirements, and project timelines.

Ensure compliance with regulatory requirements (FDA, EMA, etc.) and industry standards (GMP, GAMP, etc.).

Perform additional responsibilities as required to support successful validation project deliverables.

Requirements

Bachelor’s degree in Engineering, Life Sciences, or a related field.

3 years minimum experience of equipment commissioning, qualification, and validation engineering experience in the pharmaceutical and/or biotech industries.

Strong knowledge of regulatory requirements and industry standards.

Hands‑on experience in sterile fill‑finish environments, with demonstrated involvement in isolators and filling line validation activities.

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.

Must be authorized to work in the US.

No C2C at this time.

BenefitsEqual Opportunity Employment StatementPSC Biotech 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.#LI-RD1

PSC Biotech

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