<회사개요>
다양한 모션 제어 기술/시스템 분야의 선도적인 제조업체로, 소비재, 자동차, 산업 및 항공 분야에 사용되는 여러 가지 정밀 엔지니어링 솔루션을 공급하고 있습니다.
Position Title: Process Validation Engineer
5~10 year's experience working within GMP system
Position Summary:
To develop and maintain manufacturing equipment and document systems to assure compliance with GMP customer and regulatory requirements and the standards. This may include but not be limited to document controls, change requests, documentation, assets, training, audits, etc. Develop and implement a protocol for equipment / Product validation Responsible to secure and maintain relevant certifications and approvals to meet customer, regulatory and market requirements.
Scope/Supervision and Interaction:
Reports to the Division Manufacturing Manager. Ensure products and processes meet customer quality requirements. Interfaces with QA, SCM, Engineering, Laboratory, Sales, Maketing. As a manufacturing validation engineer, responsible for participates in the audit processes, both internal and external customer, certification and regulatory bodies.
Essential Functions:
1.Manage and improve the validation process based on GMP.
2. Validation: Develop plans and protocols for validation of existing and new equipment, manufacturing processes
, and products (including re-validation).
3.Continuously supervise equipment and document control in the process area (Batch Records, SOPs, log books).
4. Participate in internal and external audit processes (customers, certification bodies, and regulatory agencies) to
identify opportunities for continuous improvement.
5. To review a plan of change controls and verify its changes with the necessary objective evidence.
6. Provide the necessary support to ensure the effective operation of manufacturing, maintenance, and training
systems.
Job Requirements :
1.Qualifications: 4 year college degree in Industrial engineering, Chemical engineering or related department required.
2.5~10 year's experience working within GMP system, along with detailed knowledge of gaining, maintaining and developing processes and procedures.
3.Must have experience of working with a validation engineer in GMP based company, along with the ability to develop plans and protocols for the qualification and validation of equipment, manufacturing processes, and products.
4.Be good at dealing with MS Office
5.Excellent written, verbal, and interpersonal communication skills for effective interface with all internal and external contacts.
6.Good communications in English skills preferred.
<근무조건>
- 근무시간 : 09:00 ~ 18:00 ( 주 5일근무 )
- 근무지 : 경기도 화성시 장안공단
- 직급및연봉 : 면접시 경력과 능력, 직전 직장 연봉등을 참고로 협의 결정 합니다.
조회 : 2,043
