ten23 health AG seeks a Senior Process Engineer to serve as the Technical Owner for Line 1 in aseptic manufacturing, ensuring GMP compliance and operational stability in Visp, CH.
The company is looking for a Senior Process Engineer to act as the primary Technical Owner for its aseptic production Line 1. In this capacity, the individual will be responsible for the stable, GMP-compliant operation of the line throughout its entire lifecycle and will serve as the main technical spokesperson for the equipment across all internal and external stakeholder interactions.
Responsibilities
- Serve as the lead technical subject matter expert and owner for Line 1.
- Develop a thorough understanding of the line's mechanics, automation systems (PLC/SCADA), utility supplies (such as WFI and HVAC), and aseptic filling procedures.
- Establish and refine preventive and predictive maintenance plans to enhance overall equipment effectiveness (OEE) and line performance.
- Spearhead complex problem-solving efforts and facilitate root cause analyses for persistent or intricate equipment failures.
- Provide technical leadership in resolving Deviations (DRs) and implementing Corrective and Preventive Actions (CAPAs).
- Monitor malfunction data systematically and perform Pareto and OEE analyses to identify and execute efficiency improvements.
- Manage technical improvement initiatives, including equipment upgrades, GMP optimizations, and the transfer of new products or formats.
- Guarantee strict adherence to GMP standards, particularly Annex 1, and maintain the qualified status of all equipment.
- Draft, review, and maintain standard operating procedures (SOPs), technical instructions, risk assessments, and Change Controls, while acting as the technical authority during audits.
- Represent Line 1 as the primary technical contact for clients, regulatory bodies, and cross-functional teams.
- Oversee critical spare parts management and coordinate shutdown schedules with the Technical Service department.
Requirements
- A Bachelor’s or Master’s degree in Mechanical Engineering, Process Engineering, Pharmaceutical Engineering, or a closely related technical field.
- Several years of experience in technical support, maintenance engineering, or equipment lifecycle management within complex GMP production environments.
- Strong expertise in equipment technology, automation (PLC/SCADA), clean utility systems (e.g., WFI, HVAC), and a deep understanding of GMP regulations, including Annex 1.
- Willingness to participate in on-call duty to support critical operations when necessary.
Nice to have
- Prior experience working in aseptic production or sterile manufacturing settings.
What the company offers
- A flexible work environment characterized by an open culture and a diverse workforce.
- A culture focused on learning and self-development, with access to a wide variety of training opportunities.
- A competitive pension fund plan, an annual bonus, and additional financial and non-financial benefits.
About the company
ten23 health AG positions itself as a human-centric and sustainable strategic partner for the pharmaceutical industry and biotech start-ups. The organization fosters a workplace built on self-responsibility and mutual trust, prioritizing flexibility and minimizing bureaucratic hurdles.
- Human-centric approach with a focus on sustainability.
- Culture of self-responsibility and mutual trust.
- Flexible working conditions with limited bureaucracy.
- Diverse and open work environment.
Quelle: öffentlich zugängliche Karriereseite des Arbeitgebers. Batchly ist nicht der Arbeitgeber und steht nicht notwendigerweise in einem Vertragsverhältnis mit dem Unternehmen.