[Medical Device, Line Start Up Exp] 9 Months contract Equipment Validation Engineer UP$7K #HJA

Scope

* Provides technical supply support on the commercialization and manufacture of products either independently or with minimal support (seeking support / escalating efficiently where needed).

* Supports/ leads all technical/ process activities (for example) investigations, validation and qualification processes, risks assessments, process safety management activities under his/ her responsibilities and could be responsible for technical product stewardship activities.

* Supports continuous process improvement activities to enhance site performance metrics and contributes to the global organization technical network to share site experiences/ knowledge and continuously expands on personal expertise.

* Supports/leads the introduction of new products to the site and the transfer of products to other facilities.

Responsibilities

* Lead and support new product introductions, including process scale-up, equipment qualification (IQ/OQ/PQ), PPQ execution, and validation documentation for sterile medical devices/pharmaceutical manufacturing

* Design and execute process experiments to evaluate equipment and process changes, troubleshoot manufacturing issues, and implement improvements to ensure robust and compliant operations

* Provide technical support for sterile manufacturing, including monitoring CPPs, CQAs, Cpk, and sterile boundaries to maintain validated state and product quality

* Investigate deviations, product complaints, and adverse events to determine root causes and implement effective CAPA in compliance with GMP requirements.

* Support regulatory audits, change control management, cleaning validation, continued process verification, and lifecycle management activities within a pharmaceutical manufacturing environment

TELE me at @yijingggggg or WA me at https://wa.me/+6598623556 NOW!

Interested candidates, please submit your resume to [email protected]

Alison Chen

CEI Reg No: R25126657

Recruit Express Pte Ltd (EA Licence No.: 99C4599)