Pharmaceutical Device Assembly Engineer / Manufacturing SME

Pharmaceutical Device Assembly Engineer / Manufacturing SME

Employment Type: Permanent

Location: Client Site

About the Role

Adryan AG is seeking an experienced Pharmaceutical Device Assembly Engineer / Manufacturing Subject Matter Expert (SME) to support device assembly and manufacturing activities within a pharmaceutical or medical-device production environment.

The ideal candidate has hands-on experience with the assembly, operation, troubleshooting or technical support of drug-delivery devices and their manufacturing processes. Relevant products may include injection pens, autoinjectors, prefilled syringe systems and other combination products.

The role requires a practical understanding of assembly processes, manufacturing equipment, technical documentation and GMP requirements. Experience supporting automated assembly lines, robotics, process optimization and equipment qualification is particularly valuable.

Experience in pharmaceutical Fill & Finish, sterile manufacturing and single-use process systems is beneficial, especially where manufacturing activities connect with the assembly or packaging of drug-delivery products.

Key Responsibilities

• Provide technical and manufacturing support for the assembly of pharmaceutical drug-delivery devices and related products.
• Support assembly processes for devices such as injection pens, autoinjectors, prefilled syringe systems or other combination products, where applicable.
• Troubleshoot assembly equipment, process issues and manufacturing deviations, working with engineering, automation, quality and production teams.
• Support the operation, optimization and continuous improvement of manual, semi-automated and automated assembly lines.
• Interpret and apply technical documentation, equipment specifications, assembly instructions, SOPs and manufacturing records.
• Support equipment implementation, commissioning, qualification and validation activities, including FAT/SAT and IQ/OQ/PQ where applicable.
• Contribute to investigations, root cause analysis, CAPA, change control and process improvement activities in a GMP-regulated environment.
• Collaborate with cross-functional teams to improve product quality, process reliability, production efficiency and compliance.
• Provide technical guidance and act as a Subject Matter Expert (SME) for assembly processes, manufacturing equipment or related technologies.
• Support technical transfers, new product introductions and manufacturing scale-up where required.

Requirements

• Degree or equivalent technical qualification in Mechanical Engineering, Electrical Engineering, Automation, Mechatronics, Process Engineering, Biotechnology, Pharmaceutical Engineering or a related discipline.
• Hands-on experience in pharmaceutical or medical-device assembly, ideally involving drug-delivery devices or combination products.
• Practical understanding of assembly processes, manufacturing equipment and production-line operations.
• Experience troubleshooting manufacturing or assembly equipment and resolving technical process issues.
• Ability to interpret technical documentation, assembly specifications, operating procedures and manufacturing records.
• Experience working in a GMP-regulated pharmaceutical or medical-device manufacturing environment.
• Strong analytical and problem-solving skills, with the ability to work independently and collaborate across technical teams.
• Good communication skills and the ability to provide technical guidance to production and engineering stakeholders.

Preferred Qualifications

• Experience with injection pens, autoinjectors, prefilled syringe devices or other drug-delivery systems.
• Experience with automated assembly lines, robotics, PLC-controlled equipment, machine vision or functional testing.
• Experience in device assembly process development, process validation, equipment qualification or technical transfer.
• Knowledge of GMP, quality systems, deviation investigations, CAPA and change control.
• Experience with sterile Fill & Finish, pharmaceutical packaging or single-use process systems.
• Previous experience as an Assembly Engineer, Manufacturing Engineer, Process Engineer, Equipment Engineer or Assembly SME.

Interested?

If you have hands-on experience supporting pharmaceutical device assembly and manufacturing processes, and enjoy solving technical challenges in a regulated environment, we would like to hear from you.

Please submit your CV, highlighting your experience with device assembly, manufacturing equipment, automation, troubleshooting and GMP operations.