Engineering Manager (Formulation, Filling, Inspection & Packaging)

To provide effective leadership and technical ownership of engineering activities supporting Secondary Manufacturing operations including Formulation Filling Inspection and Packaging. The role ensures safe compliant and reliable operation of manufacturing equipment through effective maintenance execution continuous improvement and team development in alignment with site objectives and regulatory requirements.

Key Responsibilities

Engineering & Maintenance Leadership

• Lead manage and support a team of engineers and technicians to deliver planned and reactive maintenance across Secondary manufacturing areas.
• Ensure day-to-day maintenance activities are completed in line with the maintenance schedule with minimal impact to the operational plan.
• Coordinate and manage reactive maintenance activities ensuring rapid response and resolution while maintaining full GMP HSE and regulatory compliance.
• Provide engineering ownership for Formulation Filling Inspection and Packaging equipment ensuring high levels of performance reliability and availability.

Operational Support & Collaboration

• Work closely with Production Quality Validation and Engineering support functions to support safe and efficient Secondary manufacturing operations.
• Participate in daily operational reviews and planning meetings to align engineering activities with production priorities.
• Support execution of agreed maintenance and improvement work schedules through strong teamwork and hands-on involvement where required.

Continuous Improvement & Reliability

• Actively manage operational issues using structured problem-solving tools and continuous improvement methodologies.
• Lead and participate in Root Cause Analysis investigations and implement effective long-term solutions including the definition and execution of CAPAs.
• Develop and deploy reliability and asset care best practices to improve OEE reduce downtime and enhance equipment performance.
• Identify and lead improvement projects within Secondary operations including equipment upgrades process improvements and contractor-led activities.

Quality GMP & Compliance

• Ensure GMP standards are consistently applied within Secondary manufacturing areas in accordance with the Orange Guide CFR regulations and site procedures.
• Ensure accurate completion of all GMP documentation including maintenance records deviations investigations change controls and corrective actions.
• Investigate and report potential quality defects arising from equipment or maintenance activities and support appropriate CAPA implementation.
• Ensure all engineering activities comply with regulatory and legislative requirements including PSSR LOLER PUWER and related standards.

Health Safety & Environment

• Actively promote and demonstrate a strong safety culture within the engineering team and Secondary manufacturing areas.
• Ensure Near Misses accidents and incidents are reported investigated and addressed in line with site procedures.
• Support HSE investigations and ensure actions are implemented and closed out effectively.

Team Development & Training

• Develop coach and mentor the engineering team to build capability across Formulation Filling Inspection and Packaging technologies.
• Ensure appropriate training competency assessment and development plans are in place and fully documented in accordance with procedures.
• Support succession planning and multi-skilling to improve team flexibility and resilience.

Resource & Budget Management

• Support the management of departmental budgets to meet production demand and engineering resource requirements.
• Ensure effective utilisation of internal and external resources including contractors to deliver planned and reactive work.

Knowledge Skills & Competencies

• Strong leadership people management and coaching skills.
• Proven ability to influence and collaborate effectively across Production Quality and Engineering functions.
• Excellent problem-solving and root cause analysis capabilities.
• Strong understanding of GMP requirements within Secondary pharmaceutical manufacturing.
• Proven experience applying Operational Excellence and continuous improvement tools.
• High standards of numeracy literacy and attention to detail.
• Flexible proactive and able to perform effectively in a fast-paced regulated manufacturing environment.

Minimum Education Requirements

• Degree in Engineering (Mechanical Electrical or Chemical) or Engineering HNC.

Minimum Experience Requirements

• Proven experience leading engineering or maintenance teams in a regulated manufacturing environment.

About CSL Seqirus

CSL Seqirus is part ofCSL. As one of the largest influenza vaccine providers in the world CSL Seqirusis a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S. the U.K. and Australia CSL Seqirus utilizes egg cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.

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