Technical Services Engineer (Process & Product)

Role Summary:

• Are you driven to elevate sterile manufacturing performance, streamline tech transfers, and champion innovation within pharmaceutical operations? Our client is seeking a Technical Services Engineer to join a high-calibre Technical Services team supporting aseptic manufacturing, new product introductions, and ongoing process optimisation initiatives.
• 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.

Core Duties and Responsibilities:

• Develop, optimise, and support robust sterile manufacturing processes.
• Lead technical investigations, risk assessments, and implementation of corrective actions.
• 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.
• Analyse process data to reduce variability and strengthen process control.
• Drive continuous improvement initiatives, including Lean/Six Sigma and technology upgrades.

Minimum Qualifications and Experience:

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

 Nice to Have

• Six Sigma or Lean certification.
• Experience with automation systems (SCADA, MES).
• Knowledge of PAT tools and methodologies.
• Knowledge of process analytical technology (PAT).

Please note, we do not require agency assistance with this role.