Validation Engineer

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Validation Engineer based in the United States.

As a Senior Validation Engineer, you will lead critical validation activities supporting the development and delivery of life-enhancing therapies within highly regulated pharmaceutical, biotechnology, and medical device environments. You will oversee the validation lifecycle for equipment, utilities, facilities, computerized systems, and manufacturing processes, ensuring technical excellence and compliance with applicable quality standards. Working across complex client and technology-transfer projects, you will develop and execute qualification strategies, manage technical documentation, and help resolve validation challenges. You will also serve as a subject matter expert, partnering with Engineering, Quality, Maintenance, and other teams to keep projects on track. This role offers the opportunity to contribute to meaningful scientific and operational outcomes while mentoring colleagues and supporting continuous improvement.

Accountabilities:

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Lead the preparation and execution of validation lifecycle documentation, including FAT, SAT, IQ, OQ, and PQ, for equipment, utilities, facilities, cleaning processes, shipping systems, and other GMP-regulated assets.

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Oversee validation activities for internal and client technology-transfer projects, including authoring, executing, reviewing, and closing risk assessments, validation plans, protocols, test methods, and final reports.

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Write, review, and update qualification and verification documentation, including SOPs, validation master plans, execution plans, user and functional requirements specifications, design specifications, FAT documents, verification protocols, and commissioning procedures.

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Prepare comprehensive summary reports covering validation, verification, commissioning, and requalification activities.

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Develop and support procedures, investigations, protocols, reports, and change controls in collaboration with Maintenance, Engineering, and Quality teams.

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Lead P&ID walkdowns to verify system installation, configuration, and readiness.

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Perform and oversee thermal mapping activities for temperature-controlled chambers, warehouses, and SIP processes.

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Support the investigation and resolution of regulatory observations, audit findings, and manufacturing site issues related to validation.

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Lead periodic reviews and requalification activities for temperature-controlled systems and other validated assets.

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Provide technical guidance and mentorship to junior validation engineers and contribute to team development.

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Coordinate cross-functional validation activities to ensure alignment with project timelines, operational requirements, and quality expectations.

Requirements:

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

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7–11 years of experience in the biotechnology, pharmaceutical, or medical device industry.

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Strong understanding of FDA current Good Manufacturing Practices (cGMP), Failure Mode and Effects Analysis (FMEA), and risk-based validation principles.

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Advanced expertise in equipment validation, computerized systems validation (CSV), analytical methods, and process validation.

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Extensive experience developing protocols for automated production systems, particularly computerized equipment and systems.

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Demonstrated ability to author and review IQ, OQ, PQ, and CSV documentation and reports.

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Experience supporting regulatory inspections, audits, remediation activities, and the resolution of compliance findings.

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Strong written and verbal communication skills, with the ability to explain complex technical topics to diverse stakeholders.

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Excellent organizational, analytical, and documentation skills, with the ability to manage multiple priorities independently.

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Strong problem-solving capabilities, including experience supporting investigations and root-cause analysis.

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Proven ability to lead validation workstreams, collaborate across functions, and mentor junior team members.

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Ability to meet the role’s physical requirements, including regular computer use, walking and sitting, and occasionally lifting or carrying items weighing up to 25 pounds.

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Must be currently authorized to work in the United States, as employment visa sponsorship is not available.

Benefits:

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Annual base salary range of $110,000–$125,000 , depending on experience, qualifications, geographic location, and other job-related factors.

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Annual incentive plan.

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Comprehensive benefits package.

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Flexible paid time off and company-paid holidays.

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Flexible working hours.

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Fully remote work options for most positions, with the flexibility to work from various locations.

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Office locations available in Greater Boston, San Diego, Boulder, and India.

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Ongoing professional development, career growth, and learning opportunities.

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Employee recognition programs and a culture focused on collaboration, innovation, and individual contributions.

How Jobgether works:

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

Why Apply Through Jobgether?

Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.

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