Senior Director of Engineering

Mantell Associates; München; Vor Ort; EUR 180.000 - 260.000; Vollzeit

Zusammenfassung

Mantell Associates, in partnership with a global life sciences company, seeks a Senior Director of Engineering to drive feasibility, concept and detailed design for a new manufacturing site. You will lead integration between site leadership, Quality, and enabling functions to ensure rapid, governed progress.

The role requires 15+ years in complex manufacturing, deep process knowledge, and experience with large-scale capital projects and site start-ups.

Qualifikationen

• 15+ years of experience in complex manufacturing environments within the life sciences industry.
• Strong technical expertise in advanced therapeutic product manufacturing.
• Deep process knowledge across the manufacturing value chain.
• Experience with large-scale capital projects and site start-ups.
• Regulatory inspection experience and cross-functional leadership

Aufgaben

• Lead design phases for a new manufacturing facility from feasibility through detailed design.
• Review and contribute to facility design, utilities, equipment, and automation.
• Govern contractors and external partners with governance and steering committees.
• Establish robust project documentation, decisions, and escalation processes.
• Ensure alignment between site team, headquarters, Quality, and enabling functions.

Kenntnisse

Leadership

Project management

Stakeholder management

Manufacturing IT/Automation

Financial acumen

Communication

Ausbildung

Advanced degree (PhD, MSc, or equivalent)

Jobbeschreibung

Mantell Associates is partnered with a global life sciences company who is seeking a Senior Director of Engineering to play a critical leadership role in evaluating options and establishing a new manufacturing site, ensuring that engineering design, capital project execution readiness, and site establishment are advanced with clarity, pace, and strong governance.

This is a newly created role reporting to a senior executive within Manufacturing and Technical Operations. The position will drive development of the feasibility, concept design, basic design, and detailed design phases for a new manufacturing facility, working in close collaboration with external partners and internal colleagues across multiple locations.

The role will serve as a key integrator between the Capital Project Manager/Site Head, senior leadership, Quality, and enabling functions at headquarters, ensuring aligned decision-making, clear escalation, and shared visibility of progress for the capital project and site establishment activities.

In addition, the role will support the selection and onboarding of key contractors and partners, contribute to establishing the initial site team, and help translate the company's operating model and culture into the new manufacturing environment.

Regular travel will be required.

Senior Director of Engineering - Responsibilities:

• Lead development of the feasibility, concept design, basic design, and detailed design phases for the manufacturing facility.
• Serve as primary reviewer, and where relevant contributor, for facility design, utilities, process equipment, manufacturing IT/automation, and related engineering design elements.
• Support selection, onboarding, and governance of key contractors and external partners.
• Drive recurring project governance meetings and support steering committee preparation, follow-up, and decision tracking.
• Establish robust project documentation practices, including document hierarchy categorization, version discipline, and decision records.

Integration Between Site Team and Headquarters

• Act as the primary link between senior leadership, the Capital Project Manager/Site Head, Quality, and enabling functions at headquarters.
• Ensure leadership and the Capital Project Manager/Site Head have a shared, current view of progress, risks, decisions, and dependencies related to site establishment.
• Facilitate timely escalation and resolution of issues requiring executive alignment or cross-functional input.

Establishment of Initial Site Team

• Collaborate with senior leadership, the Capital Project Manager/Site Head, Quality, and enabling functions to establish the initial team at the new manufacturing site.
• Support development of local processes, procedures, and ways of working aligned with company standards and future operational needs.
• Help embed the company's culture, collaboration model, and quality mindset into the new site as the organization scales.

Senior Director of Engineering - Requirements:

Education

• Advanced degree (PhD, MSc, or equivalent) in a relevant scientific or engineering discipline.

Experience

• 15+ years of experience in complex manufacturing environments within the life sciences industry, including strong technical expertise in advanced therapeutic product manufacturing.
• Deep process knowledge at thought-leadership level, spanning multiple stages of the manufacturing value chain, including specialized or novel modalities and finished product operations.
• Strong understanding of manufacturing IT/automation, utilities including HVAC, process equipment, and site infrastructure.
• Proven experience with large-scale capital projects (nine-figure investment range), site start-ups, and/or facility expansions, including establishing and managing user requirements.
• People leadership experience in commercial manufacturing operations.
• Experience with validation concepts and process qualifications.
• Experience with regulatory inspections from major global health authorities.
• Excellent project leadership skills with a proven ability to establish effective collaboration with external partners.
• Strong financial acumen and ability to support disciplined capital investment decision-making.
• Strong stakeholder management and cross-functional collaboration capabilities.
• Excellent communication skills and ability to navigate across all organizational levels