Jobid=42a55a91b72c (0.1014)
Job Description
As a Manufacturing Engineer, you will be responsible for guiding the introduction of new production equipment from concept to full integration. You will collect technical requirements, support design decisions, and prepare validation plans for both hardware and software components. You will create detailed documentation, lead validation activities, and ensure all steps align with quality and regulatory standards. A key part of this role is collaborating with internal departments and external partners to resolve technical issues, assess risks, and support the smooth handover of equipment to operational teams. You will contribute to continuous improvement initiatives and help shape robust manufacturing processes.
Responsibilities
- Write technical protocols and execute validation activities in collaboration with subject matter experts.
- Collect user needs and specifications for equipment, including documentation such as URS, test plans, and qualification protocols.
- Act as a subject matter expert for GxP, GMP, and computerized system validation.
- Lead change control and validation tasks from initiation through closure.
- Communicate with departments such as R&D, Quality, Operations, and suppliers to support project goals.
- Implement equipment validation to support global scalability of processes.
- Develop and carry out test strategies, validation reports, and related documentation.
- Evaluate product and process requirements and perform risk and root‑cause analyses.
- Improve and define product, process, and equipment designs and requirements.
- Set up and execute engineering, validation, and verification studies, including analysis and reporting.
- Plan and coordinate the introduction of new or updated equipment and processes, including SOPs, risk assessments, and training.
Requirements
- Bachelor's degree in Mechanical, Electrical, or related Engineering discipline.
- At least 5 years' experience in manufacturing or industrial engineering within a high‑volume environment.
- Strong command of English, written and verbal.
- Knowledge of design for manufacturing principles, lean concepts, and tolerance methods.
- Experience using statistical tools, preferably with Minitab.
- Solid understanding of GMP, GxP, and computerized system validation.
- Hands‑on mindset and ability to collaborate effectively across teams.
- Proven validation experience in a regulated industry such as medtech or pharma.
- Preferred qualifications include: advanced degree, experience with metrology, vision systems, SCADA validation, high‑precision machining, injection molding, and Six Sigma certification.
Benefits
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