As Senior Process Engineer at Nanomi, you will play a key role in shaping and strengthening our aseptic manufacturing capabilities for long‑acting release injectable products. You will design, optimize, and maintain robust pharmaceutical processes for GMP‑regulated environment, ensuring our microsphere and nanoparticle technologies can reliably scale from R&D into clinical and commercial production.
In this senior role, you act as a technical expert on aseptic processing, providing leadership in process design, troubleshooting, technology transfer, and validation. You will work closely with our R&D teams, Quality departments, and Contract Manufacturing Organizations (CMOs) to secure safe, compliant, and efficient operations across all sites involved.
Responsibilities
- Lead development, qualification, and optimization of aseptic and sterile manufacturing processes for long‑acting injectables.
- Define, maintain, and document critical process parameters (CPPs) and critical quality attributes (CQAs)
- Drive process improvements aimed at increasing efficiency, yield, robustness, and scalability.
- Provide technical GMP support, including investigations (deviations), CAPAs, change controls, and batch-related troubleshooting.
- Serve as subject matter expert (SME) for aseptic processing, cleanroom behavior, contamination control, and microbiological risk mitigation.
- Ensure compliance with applicable regulatory and quality standards (EU GMP Annex 1, FDA, ICH).
- Prepare, review, and maintain process documentation such as batch records, protocols, and technical reports.
- Lead process validation activities, including process performance qualification (PPQ).
- Support the selection, commissioning, and qualification of aseptic processing equipment (e.g., isolators, filling machines, sterilization systems).
- Collaborate with CMOs and GMP-manufacturing sites in resolving technical challenges and improving process performance.
- Conduct structured process risk assessments (FMEA, HACCP) and apply statistical/analytical tools.
- Act as technical mentor for junior engineers, technicians, and laboratory staff.
- Partner with Quality Assurance, Formulation Development, and Analytical Chemistry teams to ensure alignment on process readiness and product requirements.
What do you bring?
- Master’s degree in Chemical Engineering, Biotechnology, Pharmacy, Mechanical Engineering, or related field
- 10+ years of experience in pharmaceutical or biotech manufacturing
- Proven experience working in GMP environment and aseptic/sterile processing
- Demonstrating experience with process validation, technology transfer, and equipment qualification.
- Strong knowledge of GMP regulations, EU Annex 1, and aseptic processing industry standards.
- Expertise in sterile filtration, aseptic filling, contamination control, and cleanroom operations.
- Experience with process modelling, data analysis, or statistical tools is a plus.
- Strong problem-solving mindset, analytical skills, and structured approach to decision-making.
- Excellent communication skills and the ability to translate technical concepts into clear documentation.
What do we offer?
We offer you an interesting position in a growing organization, in which you get the opportunity to develop yourself. You will get great colleagues and will be part of an enthusiastic team.
Joining Nanomi means entering a challenging and fun workplace with ambitious and talented people. We are a dynamic, R&D-driven organization with a constant focus on innovation and ground-breaking technologies and products, in order to make a real difference for the patient. At Nanomi initiative is valued, daring is rewarded, and we encourage you to explore and ‘push the boundaries’. We embrace our company values Teamwork, Respect & Care, Integrity, Passion for Excellence, Customer Focus and Entrepreneurial Spirit. We find it important to spend time together as a team.
In addition you will get:
- 30 days off based on full-time employment
- A yearly bonus
- A good pension scheme
- Flexible working hours and working from home is possible to the limit of 1 day /week.
- Delicious coffee, fresh fruits on the house and “bad” snacks
- An inspiring environment with room for training and development
- Nice Friday afternoon drinks (Vrijmibo’s), lunch & Learns en team trips
