Process Engineer, Aseptic Production e/v/e/r/y/o/n/e

ten23 health is a human-centric and sustainable strategic partner of choice for the pharmaceutical industry and biotech start-ups for the development, manufacture, and testing of tomorrow’s medicines. We support our clients in developing differentiated, stable, usable, and safe injectable treatments for patients.

We are seeking a dedicated Process Engineer, Aseptic Production to step in as the Technical Owner for our production Line 1 in aseptic manufacturing. In this pivotal role, you will ensure the stable, GMP-compliant operation of the line throughout its entire lifecycle. This position requires deep technical equipment and process expertise to drive sustainable troubleshooting, optimize equipment availability, and lead technical projects while acting as the primary spokesperson for the line across internal and external stakeholders.

Your responsibilities will include,

• Act as the primary technical subject matter expert (SME) and Technical Owner for Line 1.
• Maintain and build a comprehensive understanding of equipment mechanics, automation (PLC/SCADA), utility supplies (WFI, HVAC), and aseptic filling processes.
• Define, evaluate, and refine preventive and predictive maintenance strategies to maximize line performance and OEE (Overall Equipment Effectiveness).
• Lead complex problem-solving initiatives and moderate root cause analyses (e.g., 5-Why, Fishbone, FMEA) for recurring or complex equipment malfunctions.
• Drive technical contributions and sustainable resolutions for Deviations (DRs) and CAPAs.
• Systematically track malfunction data and conduct Pareto and OEE analyses to drive targeted improvements in efficiency and process stability.
• Lead technical improvement projects, including equipment modifications, GMP optimizations, and the introduction of new formats and products (Tech Transfers).
• Ensure strict adherence to GMP compliance (specifically Annex 1) and take responsibility for maintaining the qualified state of the equipment.
• Create, maintain, and review SOPs, technical instructions, risk analyses, and Change Controls, acting as the technical expert during audits and inspections.
• Act as the primary technical spokesperson for Line 1 in interactions with clients, regulatory authorities, and cross-functional teams (Production, QA, MSAT, Engineering).
• Manage critical components, spare parts strategies, and coordinate shutdown planning closely with Technical Service.

We are looking for someone with:

• Bachelor’s or Master’s degree in Mechanical Engineering, Process Engineering, Pharmaceutical Engineering, or a related technical discipline.
• Several years of professional experience in technical support, maintenance engineering, or equipment lifecycle management within complex GMP production facilities.
• Proven experience in aseptic production or sterile manufacturing environments is highly advantageous.
• A strong foundation in equipment technology, automation (PLC/SCADA), clean utility systems (e.g., WFI, HVAC), and deep knowledge of GMP requirements (including Annex 1).
• Strong analytical mindset with a structured, data-driven approach to troubleshooting and root cause analysis.
• High level of personal accountability, an ownership mentality, and the ability to take full responsibility for line performance.
• Excellent ability to translate and communicate complex technical issues clearly to diverse, cross-functional stakeholders.
• Assertiveness and leadership capabilities within a fast-paced production environment.
• Flexibility and willingness to participate in on-call (picket) duty to support critical operations.