Job Description

The Senior Validation Engineer will join a highly skilled team responsible for managing the commissioning and qualification (C&Q) of fully automated packaging equipment for biotech drug products.

Reporting to the Ultimate Solutions C&Q Lead or Characterization Lead, the Senior Engineer will take a leadership role in executing validation strategies and coordinating with client leads. This position also involves mentoring and overseeing Junior Validation Engineers, ensuring all validation deliverables meet project timelines and compliance standards.

Key Responsibilities

• Lead packaging equipment validation activities including the development and execution of IQ, OQ, PQ protocols and traceability matrices.
• Coordinate and manage validation projects in alignment with client schedules and expectations.
• Oversee Junior Validation Engineers, providing technical guidance and ensuring quality of work.
• Ensure full compliance with FDA regulations, cGMP, and industry best practices throughout validation activities.
• Collaborate with cross-functional teams including Engineering, QA, and Operations to support successful commissioning and qualification.
• Generate, execute, and review validation documentation, protocols, and reports.
• Support packaging equipment field execution and troubleshoot issues during qualification phases.
• Participate in project planning meetings and provide regular status updates to client leads and internal stakeholders.
• Identify and mitigate project risks, proactively ensuring validation milestones are met on time.
• Adapt to changing schedules and priorities, including the ability to work extended shifts, weekends, and travel on short notice when required.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• Minimum 5 years of experience in equipment validation within biotech, pharmaceutical, or medical device industries.
• Proven expertise in validation lifecycle documents (IQ/OQ/PQ, protocols, traceability matrix, etc.).
• Solid understanding of FDA validation guidelines, cGMP, and regulatory requirements.
• Experience working in regulated manufacturing environments with complex, automated packaging systems.
• Strong technical writing and documentation skills.
• Ability to work independently, manage priorities, and lead project segments.
• Excellent interpersonal and communication skills.
• Willingness to work flexible hours and travel as needed (up to 25%).

Ultimate Solutions USA, LLC is an equal opportunity employer. The company prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Job Tags

Flexible hours, Shift work, Weekend work,

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