Validation Engineer

PSC Biotech Corporation; Boston (MA); On-site; USD 80,000 - 105,000; Full time

Job summary

PSC Biotech Corporation is seeking a Validation Engineer to join their team. This role involves commissioning, qualification, and validation within the pharmaceutical and biotech sectors, ensuring compliance with regulatory standards. Candidates should have a Bachelor’s degree and relevant experience in validation processes.

Qualifications

• 3-5 years of validation experience in pharmaceutical/biotech industries.
• Strong knowledge of regulatory standards and validation lifecycle management.
• Experience with risk-based approaches.

Responsibilities

• Develop and execute commissioning, qualification, and validation protocols.
• Maintain comprehensive documentation including protocols, plans, and reports.
• Ensure compliance with regulatory requirements (FDA, EMA) and industry standards.

Skills

Analytical skills

Technical skills

Documentation skills

Communication skills

Project management

Education

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

Job description

Join to apply for the Validation Engineer role at PSC Biotech Corporation.

PSC Biotech provides essential services to the life sciences industry, ensuring health care products are developed, manufactured, and distributed to the highest standards, in compliance with 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, contributing to our clients' achievements.

The Experience

With a diverse, multicultural team worldwide, PSC Biotech fosters an inspiring environment for career growth, professional development, and collaboration. We value and nurture talents, offering competitive compensation and development tools.

At PSC Biotech, it’s about your career and future, not just a job.

Your Role

We are accepting applications for future opportunities. Join our talent pool for upcoming openings. This is a W2-temp role for 6 months with potential extension to FTE. We seek experienced validation engineers responsible for commissioning, qualification, and validation of facilities, utilities, and equipment in the pharmaceutical and biotech industries. Your role includes supporting validation planning, documentation, execution, and ensuring compliance with regulatory standards and quality requirements.

• Develop and execute commissioning, qualification, and validation protocols for equipment and systems.
• Maintain comprehensive documentation, including protocols, plans, reports, and SOPs.
• Assess risks associated with CQV activities and develop mitigation strategies.
• Troubleshoot and resolve equipment and process issues.
• Collaborate with cross-functional teams to ensure alignment on project timelines and activities.
• Ensure compliance with regulatory requirements (FDA, EMA) and industry standards (GMP, GAMP).
• Perform additional responsibilities to ensure successful validation deliverables.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 3-5 years of validation experience in pharmaceutical/biotech industries.
• Strong knowledge of regulatory standards and validation lifecycle management.
• Experience with risk-based approaches.
• Excellent analytical, technical, and documentation skills.
• Effective communication and interpersonal skills.
• Proactive with strong organizational and project management skills.
• Detail-oriented with a commitment to quality and compliance.
• Willingness and ability to travel for project assignments and client engagements.

PSC is committed to Equal Employment Opportunity, prohibiting discrimination based on race, color, religion, sex, national origin, age, disability, genetic information, or other protected statuses.

Additional Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Quality Assurance