Job Description

The Equipment Qualification Engineer is responsible for ensuring that all manufacturing and packaging equipment within the fill-finish operations of a pharmaceutical manufacturing facility is qualified, validated, and maintained in accordance with regulatory standards (such as FDA, EMA, cGMP). This role is vital to ensuring product quality and regulatory compliance, focusing on commissioning, qualification, and maintaining efficient operations across all equipment and cleanroom environments.

Key Responsibilities

• Develop and Execute Qualification Protocols
• Author, review, and execute equipment qualification (IQ/OQ/PQ) protocols for fill-finish equipment (e.g., vial fillers, syringe and cartridge systems, washers, depyrogenation tunnels, autoclaves, isolators, lyophilizers).
• Oversee and perform equipment commissioning activities, ensuring all systems are installed and function according to design specifications.
• Participate in FAT (Factory Acceptance Testing) and SAT (Site Acceptance Testing).
• Documentation and Compliance
• Ensure all qualification and validation documents comply with regulatory requirements and company SOPs.
• Maintain accurate, legible, and complete documentation for all activities, following data integrity guidelines (ALCOA+ principles).
• Problem Solving & Deviation Management
• Investigate qualification/validation deviations and out-of-specification results.
• Collaborate with maintenance, manufacturing, engineering, and quality assurance to resolve technical issues.
• Cross-functional Collaboration
• Work closely with Manufacturing, QA, Validation, and Engineering teams to introduce new equipment and improve existing processes.
• Provide subject-matter expertise on fill-finish system requirements, risk assessments, and regulatory trends.
• Continuous Improvement
• Identify opportunities to streamline qualification processes, improve system reliability, and implement best practices.

Qualifications

• Bachelor’s or Master’s degree in Engineering (Mechanical, Electrical, Chemical, or related discipline) or related science field.
• 2+ years of experience in pharmaceutical or biotechnology manufacturing, with demonstrated expertise in equipment qualification and validation.
• Prior experience with aseptic fill-finish processes is strongly preferred.
• Strong understanding of cGMP, FDA, and EU regulations for drug manufacturing, especially regarding validation and qualification.
• Excellent analytical thinking, technical writing, and communication skills.
• Ability to manage multiple projects and adapt to evolving priorities.

Desired Skills

• Knowledge and hands-on experience with validation of process automation and computerized systems (CSV, GAMP5).
• Familiarity with risk-based qualification approaches (FMEA, QbD).
• Proficient with qualification software and electronic document management systems.
• Strong organizational skills and attention to detail.

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