Technical Lead – Device & Packaging Industrialisation (Respiratory Combination Products)
Location: Belgium or UK | International travel required.
We’re seeking a technical leader to industrialize and scale up device assembly and packaging processes for respiratory combination products (e.g., inhalers, drug–device systems). This role sits at the interface of R&D, manufacturing, and quality, translating innovative concepts into validated, manufacturable processes and ensuring smooth tech transfer to contract manufacturing organizations (CMOs).
Core Focus Areas
* Device & Packaging Industrialisation: Develop and deploy scalable assembly, packaging, and process technologies for inhalation devices and combination products.
* Tech Transfer to CMOs: Manage the full lifecycle from concept → equipment design → FAT/SAT → validation → commercial readiness.
* Equipment & Process Development: Lead design, procurement, and qualification of assembly, filling, and packaging equipment; manage URS/RFQ/FAT/SAT documentation.
* Cross-Functional Collaboration: Work closely with Device Development, Quality, Operations, CMC, Regulatory, and external CMOs.
* Regulatory & Quality Compliance: Support design control, risk management, and validation documentation per GMP and regulatory standards.
* Continuous Improvement: Drive process efficiency and cost of goods (COGs) reduction at CMOs.
Key Responsibilities
* Act as technical lead for device & packaging industrialisation projects.
* Develop URS and manage RFPs/RFQs for equipment vendors.
* Review and approve vendor design and validation documentation (FDS, HDS, SDS, FMEA, FAT/SAT).
* Oversee technology transfer and validation of new equipment at CMOs.
* Support component specification, DFM/DFA, and validation activities.
* Maintain Design History Files (DHFs) and Technical Files.
* Provide technical input for regulatory submissions and health authority queries.
* Support inspection readiness and ongoing QA post-transfer.
Experience & Background Sought
* Education: Bachelor’s or higher in Engineering, Technology, or related field.
* Industry Experience: Strong background in inhalation or parenteral devices, or combination product development/manufacturing.
* Industrialisation Experience: Proven success scaling up and transferring processes (lab → pilot → commercial).
Technical Skills:
* Device assembly & packaging technologies
* GMP and equipment validation (IQ/OQ/PQ)
* URS, RFP/RFQ, FAT/SAT documentation
* Design Control and DHF management
* Risk management (FMEA, DFMEA)
* CMC interface and regulatory support
* Aseptic fill-finish (nice to have)
Interested? Apply now for immediate consideration or contact Lloyd Broomes on +44 203 928 8386 – LBroomes@planet-pharma.co.uk
We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age. Planet Pharma is an Employment Business providing Global Staffing services.