Technical Services Engineer – Sterile Manufacturing (Process & Product)

Description

In this key role, you will collaborate closely with colleagues across Production, Quality, Engineering, and Regulatory functions to enhance processes, resolve operational challenges, and maintain robust, compliant performance from development through to commercial manufacturing.

• Support process validation activities and ensure compliance with cGMP and global regulatory standards.
• Provide on-the-floor technical expertise to troubleshoot issues and enhance process performance.
• Support new product introductions and technology transfers across development and commercial stages.
• Develop, optimise, and support robust sterile manufacturing processes.
• Drive continuous improvement initiatives, including Lean/Six Sigma and technology upgrades.
• Analyse process data to reduce variability and strengthen process control.
• Lead technical investigations, risk assessments, and implementation of corrective actions.

Requirements

• Experience with automation systems (SCADA, MES).
• Bachelor’s or Master’s in Chemical Engineering, Pharmaceutical Engineering, Biotechnology, or related area.
• Hands-on familiarity with isolators, filling lines, autoclaves, depyrogenation tunnels, lyophilizers, and related equipment.
• Experience with validation (PPQ), DOE, SPC, and cGMP documentation.
• Knowledge of PAT tools and methodologies.
• Six Sigma or Lean certification.
• Strong understanding of aseptic processing, terminal sterilization, lyophilization, and sterile facility operations.
• Minimum 2 years’ experience in sterile injectables or biologics manufacturing.
• Knowledge of process analytical technology (PAT).
• Excellent communication, problem solving, and cross-functional collaboration skills.
• Proficiency with data analysis tools (e.g., Minitab).
• 3–7 years’ experience in pharma manufacturing, process engineering, or technical services.

Benefits

Training + Development

Interview process

Visa Sponsorship

Security clearance