Process Engineer

We are seeking a motivated professional to support both small- and large-molecule drug product manufacturing within a leading biopharmaceutical facility. Operating as part of a global process development function, this individual will play a central role in optimizing process performance and ensuring robust product and process support for commercial and clinical drug product operations.

Key Responsibilities

• Deliver technical support for drug product manufacturing, ensuring consistency, compliance, and high process performance standards.
• Independently execute process design and qualification activities.
• Prepare and review protocols, reports, and technical documentation.
• Participate in batch simulation exercises to evaluate facility fit and identify improvement opportunities within visual inspection processes.
• Contribute to new product introductions by developing and characterizing visual inspection methods and automated visual inspection (AVI) systems for new inspection lines.
• Provide subject-matter expertise in defect classification and analysis, maintaining and updating defect libraries as needed.
• Mentor and support the development of visual inspection team members through knowledge sharing and guided training.
• Support process optimization through characterization and qualification of AVI vision recipes.
• Offer technical input for both manufacturing and commercial operations to maintain efficiency and product quality.
• Lead or assist in resolving process-related deviations, root cause analyses, and troubleshooting issues related to drug product processing and equipment.
• Maintain audit readiness and provide support during GMP inspections.

Basic Qualifications

• Bachelor's degree in Science, Engineering, or a related discipline with 2-3 years of relevant experience, or
• Master's degree with at least 2 years of directly related experience.
• Experience working in a regulated environment and/or with vision inspection systems.

Preferred Qualifications

• Over 3 years of experience in drug product process development within the pharmaceutical or biotechnology sector.
• Familiarity with the development of both liquid and lyophilized drug products in multiple presentation formats.
• A collaborative mindset and a curiosity-driven approach to problem-solving, particularly in supporting inspection process needs.
• Proven ability to think independently while working effectively within cross-functional teams.
• Excellent communication and interpersonal skills.
• Strong analytical and troubleshooting abilities with a passion for identifying and addressing root causes of complex technical issues.