Process Engineer
Overview
The Process Engineer supports manufacturing operations by leading process development, validation, equipment implementation, and continuous improvement initiatives. This role focuses on enhancing quality, efficiency, and cost-effectiveness while ensuring compliance with regulatory and internal standards.
Key Responsibilities
* Drive process development and optimization projects, exploring new technologies and improving existing manufacturing methods.
* Ensure manufacturing processes meet documentation, capacity, quality, and cost objectives.
* Lead or support equipment design, material testing, and process validation activities, including the creation of technical documentation (specifications, protocols, and reports).
* Manage or participate in engineering projects, defining scope, schedules, costs, and progress reporting.
* Conduct root cause analyses and lead corrective and preventive actions (CAPA), addressing Nonconformances (NC) and audit observations.
* Provide day-to-day production support for manufacturing areas such as assembly, finishing, packaging, and material processing.
* Plan and execute process validation protocols (IQ, OQ, PQ, CSV, TMV) in accordance with relevant standards.
* Identify and implement process improvements using
Lean
,
Six Sigma
, and other structured problem-solving methodologies.
* Support the acquisition and validation of new manufacturing equipment, including user requirement specifications, vendor selection, installation, and training.
* Develop and maintain manufacturing and inspection procedures to ensure robust and compliant processes.
Candidate Requirements
* Bachelor's or Master's degree in
Mechanical Engineering, Industrial Engineering, Manufacturing Engineering
, or a related technical field.
* 2–4 years of experience in
manufacturing, process engineering, or production support
, ideally in a regulated or high-precision environment.
* Strong understanding of
process validation
,
equipment qualification
, and
quality management systems
.
* Proficient in both English and German (minimum C1 level)
— required for effective collaboration in a multilingual workplace.