Head of Production

Company: Vivalyx GmbH
Location: Berlin
Tags: Engineering

<p>At Vivalyx, a medical technology startup based in Aachen, we're on a mission to save the lives of those suffering from organ failure. Our innovative approach aims to significantly improve the vitality and availability of donor organs. As we are scaling, we're seeking a <strong>Head of Production – Omnisol (m/f/d) to join us starting as soon as possible, for 32-40 hours per week.</strong></p>
<p>We provide the opportunity to work on groundbreaking technology that has a meaningful impact. You'll be part of a dynamic, highly skilled, and motivated team. We prioritize flexibility, offering mobile working conditions and a flat hierarchical structure. In addition, we support professional development and career growth, along with an attractive employee participation program.</p>
<p>The Head of Production – Omnisol will build and lead the production and operational setup required to ensure sufficient and reliable supply of Omnisol for patients and physicians across Europe. This role will own the development of the production model, including process design, supplier setup, production scale-up, facility build-up, validation, and operational readiness to support growing demand across the European market.</p>
<p>The role has a strong operations focus and requires a highly credible, hands-on senior professional who can combine strategic judgment with pragmatic execution. While quality assurance is not the core focus of the position, it is an important part of the role and must be addressed as an integrated component of production and operational decision-making.</p>
<p>The position sits within a regulated European medtech environment and requires close collaboration with regulatory and quality functions to ensure that production-related activities are established and maintained in line with applicable ISO standards, the European Pharmacopoeia, and the requirements of the EU Medical Device Regulation (MDR; Regulation (EU) 2017/745).</p>
Tasks
<p>The Head of Production – Omnisol will establish the production and operational foundation needed to supply the European market reliably and at scale. The role is responsible for ensuring that the right production capacities, processes, partner structures, and operational controls are in place so that sufficient Omnisol is available to meet the needs of patients and physicians across Europe.</p>
<p>This includes shaping the production setup, supporting supplier and manufacturing structures, driving validation and production readiness, and helping build an operating model that can meet the requirements of the European regulated environment**. The role requires comfort moving between strategic production decisions, cross-functional coordination, and hands-on resolution of operational issues.**</p>
Requirements
<p>The ideal candidate brings substantial experience in production, operations, and scale-up within a regulated environment and is comfortable taking responsibility in a setting where structures are still being built. The role requires a strong combination of strategic thinking, implementation discipline, and sound judgment.</p>
<p>This position would suit someone who is able to translate complex requirements into robust processes, navigate ambiguity without losing momentum, and work effectively across technical, operational, regulatory, and external stakeholder interfaces. A background that combines STEM or laboratory exposure with experience in structured problem-solving environments, including consulting, could be highly relevant if paired with sufficient operational credibility and implementation strength.</p>
<p>Required Qualifications</p>
<ul>
<li>Passion for working in medical technology development</li>
<li>Strong sense of ownership, reliability, and attention to detail</li>
<li>Confidence in identifying issues early, speaking up when needed, and driving decisions in a constructive and solution-oriented manner.</li>
<li>Fluent in English, both written and spoken (German is a strong plus)</li>
<li>Degree in engineering, life sciences, chemistry, bioprocessing, operations, or another relevant technical or scientific discipline.</li>
<li>Significant professional experience in production, manufacturing, operations, or process scale-up in a regulated environment.</li>
<li>Experience working within or alongside quality and regulatory requirements relevant to the European medtech, healthcare, or life sciences market.</li>
<li>Proven experience building or scaling production-related processes and infrastructure.</li>
<li>Experience working with external suppliers, manufacturers, or other critical operational partners.</li>
<li>Ability to work on-site at least twice a week in our production facility next to Berlin</li>
</ul>
<p>Preferred Qualifications</p>
<ul>
<li>Experience in start-up or high-growth environments.</li>
<li>Experience in the European medtech, medical device, biotech, or broader regulated life scienc…