Manufacturing Engineer

About the Company  An international medical device manufacturing organization is seeking an experienced Manufacturing Engineer to support equipment implementation and validation activities within a highly regulated production environment. In this role, you will work closely with engineering, quality, operations, and R&D teams to introduce new manufacturing technologies and equipment while ensuring compliance with quality and regulatory requirements. The position offers the opportunity to contribute to global manufacturing scalability and continuous improvement initiatives.

Role Description  As Manufacturing Engineer, you will be responsible for leading equipment validation and implementation activities across manufacturing operations. Acting as a validation subject matter expert, you will develop and execute validation strategies, create technical documentation, and ensure new equipment and processes meet business, quality, and regulatory requirements. You will play a key role in supporting the full lifecycle of equipment implementation, from requirements gathering and qualification through validation, deployment, and handover to operations.

Key Responsibilities   Lead equipment implementation and validation activities within manufacturing operations
Develop and execute validation strategies for new equipment and manufacturing processes
Write and execute validation documentation including URS, TM, FAT, IQ, OQ, PQ, Validation Plans and Validation Summary Reports
Gather requirements, user stories, and technical specifications for manufacturing equipment and software systems
Act as Subject Matter Expert (SME) for GMP, GxP, and Computer System Validation (CSV) requirements
Lead change control activities from initiation through closure, including protocol development, execution, reporting, and approval
Collaborate with Engineering, Quality Assurance, Operations, R&D, and external suppliers throughout project execution
Support equipment scalability and standardization across global manufacturing sites
Design, develop, and implement test plans and validation protocols
Perform equipment qualification and process validation activities
Support documentation, training, and knowledge transfer to operational teams
Ensure compliance with regulatory and quality requirements throughout implementation projects
Requirements   Bachelor's degree in Mechanical Engineering, Electrical Engineering, Industrial Engineering, or a related technical discipline
Minimum 5 years of experience in Manufacturing Engineering and/or Industrial Engineering within medium to high-volume manufacturing environments
Proven experience as a Validation SME within Medical Devices, Pharmaceuticals, or another highly regulated cGMP environment
Strong knowledge and practical experience with GMP, GxP, and CSV principles
Experience leading validation projects and equipment qualification activities

Experience with change control processes and validation lifecycle management
Strong technical writing skills with experience creating validation and qualification documentation
Excellent communication and stakeholder management skills
Hands‑on mentality with strong cross‑functional collaboration capabilities

#J-18808-Ljbffr