Validation Engineer

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.

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

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

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

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

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

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

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

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

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

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

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

• 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.

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