Our client is a global leader in the biotech industry, employing over 40,000 staff worldwide and generating over 30 billion in revenue in 2023. This industry leader is making significant investments in its internal Biologics manufacturing operations. They are developing a pioneering Drug Product Biotech and Device/Packaging manufacturing campus at their greenfield site in Germany.

Once completed, this next-generation Biotech manufacturing plant will be one of the organization's most technically advanced Drug Product manufacturing operations, representing a 2.5 billion USD investment by the organization.

Be a collaborative, inclusive and dynamic leader, supporting the broader lead team to:

• Build the organisation with the essential capability, capacity and culture to operate this facility to the highest standards of safety, quality, and operational excellence: talent management, development, and retention within the organisation (and beyond).
• Establishes the site engineering priorities and roadmap to develop and implement the essential systems and processes for site operations. This includes demonstrating existing business knowledge, but also incorporating external experiences and learning and using Engineering first principles.
• Collaborate with the IT function to build a digital facility and operation, achieving the highest levels of digitalization and automation.
• Support the project team to deliver the facility as the end user. Offering insights, feedback and support on design decisions, commissioning strategies, startup plans, etc. Collaborate to ensure the right decisions are made to meet project deliverables and longer-term strategic goals.
• Develop and adapt organisational structure to provide accurate and capable resources and management to achieve full scale GMP manufacturing scale.
• Ensure that systems are established and implemented to achieve an initial qualified and safe state for equipment, processes, utilities, and facilities.
• Build technical relationships with the relevant corporate departments and sponsor strategic corporate initiatives at a site level.
• This position involves direct interactions with regulatory agencies.
• Continue to establish and support engineering priorities and roadmap, ensuring the integration of the functional agenda with site priorities.
• Ensure the site aligns with corporate standards and policies for the engineering function, including applicable environmental, safety, and quality requirements.
• Have external focus, and benchmark standard methodologies across the network and externally.
• Ensure equipment, processes, utilities and facilities remain and operate in a qualified and safe state and equipment maintenance and utilities operations are performed and documented to the highest standards.
• Lead the site investment processes for assets (planning, prioritisation, resourcing, project management, capital accounting and reporting). Be responsible for the development and delivery of the capital investment plan in accordance with site objectives for new products, recapitalisation of assets, and facility modernisation.
• Ensure that a robust control system exists to lead the business, identify compliance issues and raise issues appropriately.
• Develop the next generation of management and technical leaders, with potential for global roles.
• Champion continuous improvement and Lean manufacturing principles.

Basic Qualifications

• Minimum of a Bachelor's degree (or equivalent) in a relevant discipline, minimum of 10+ years of experience in a leadership role leading operations within the bio/pharmaceutical industry.
• Must possess knowledge and understanding of cGMPs and how they apply to manufacturing operations.
• Must possess a strong capability to build effective relationships at all levels
• Collaborate closely with the Site Leadership team to ensure alignment with corporate objectives and internal decision-making processes.
• Capability to connect, collaborate and communicate effectively with all levels of the organisation on site.
• Must have a history of successfully developing, leading, and implementing projects from inception to completion, on time and within budget, while maintaining high performance standards.
• Must have experience in developing and leading highly proficient, dynamic, and high-performing teams, with a focus on encouraging strong team culture to build and maintain a safe and successful work environment.
• Fluent in English and German.

To discover more about this opportunity, apply now or contact Shane Browne at HRM Search Partners on +353 1 6321865 for a confidential discussion.