Senior Engineer – Process Development (Drug Product: Filling & Single Use Technologies)

Overview

Our client is seeking a highly experienced and motivated Senior Process Development Engineer to support the development of syringe filling and single-use system (SUS) technologies for sterile drug product formulation and filling processes.

The role will be directly involved in several high-impact projects, including the characterization and qualification of new technologies for two syringe filling lines, forming part of a major site expansion initiative. The successful candidate will also provide technical support to both small and large molecule drug product manufacturing operations and will contribute within a global Process Development organization.

Key Responsibilities

• Lead the development and implementation of single-use systems for drug product formulation and sterile filling, in collaboration with site and global teams.
• Author, review, and verify qualification protocols and packages for SUS systems.
• Provide hands-on support for filling characterisation, including recipe development, protocol execution, and reporting.
• Lead and contribute to risk assessments related to drug product operations, implementing appropriate CAPAs where necessary.
• Offer technical expertise in sterile processing, process characterization, SUS, and filling technologies.
• Support investigations, NCs, and CAPA assessments related to drug product processing, in coordination with manufacturing and support functions.
• Troubleshoot issues involving drug product processing equipment and technologies using data-driven methodologies.
• Lead or support root cause analysis and deviation resolution efforts.
• Engage cross-functional and potentially cross-site teams to advance project goals and provide recommendations to leadership.
• Ensure compliance with all applicable quality regulations (e.g., FDA, EU, global standards).
• Review and post-approve process validation documents from a quality system standpoint.
• Contribute to product quality reviews, process flow mapping, and process documentation.
• Liaise with Engineering, Operations, and external vendors to support the integration of new or modified equipment into validated manufacturing processes.

Basic Qualifications

• Bachelor’s degree in Science, Engineering, or a related discipline with 5+ years of relevant experience, OR
• Master’s degree with 3+ years of relevant experience, OR
• Associate’s degree with 10+ years of directly related experience.
• Strong working knowledge of cGMP, regulatory requirements, and aseptic manufacturing technologies.
• Proven problem-solving ability and strong oral and written communication skills.
• Experience in the design and implementation of formulation SUS systems and sterile filling solutions.

Preferred Qualifications

• 10+ years in commercial drug product processing, particularly in sterile manufacturing, tech transfer, validation, or process characterization.
• Expertise in the engineering and scientific principles underpinning formulation, filtration, filling, and mixing processes.
• Knowledge of protein biochemistry, with focus on chemical and physical stability.
• Hands-on experience with drug product filling technologies such as peristaltic pumping and time-pressure filling systems.
• Deep understanding of quality systems, validation strategies, and GMP compliance.
• Demonstrated success in leading cross-functional teams and advancing complex technical projects to completion.

Excellent communication and technical writing skills