Sr. PCT Validation Engineer
Your tasks and responsibilities
Who you are
computerized system and production equipment etc..
2 In charge of engineering relevant qualification and validation work
to new equipment and systems introduced in site and capital investment
3 Draft and ensure all relevant GMP documentation preparation and
approvals including FAT/SAT, IQ/OQ/PQ protocols, reports and SOPs etc.
timely, and all technical activies meet GMP requirement.
4 Provide technical analysis and GMP risk assessment, to mainten and
improve the GMP level continiously inside engineering.
5 Keeping align and working close with otherfunctions to ensure all
engineering relevant activities in utility area could meet GMP standard
6 Track and follow technical change procedures, update status
7 Keep contact with Head quarter experts to updatenew GMP
policy,directives and follow the technology change/development
WHO YOU ARE
1. Pharma engineering/Automation/HVAC etc. background, bachelor
degree, at least more than 8 years validation experience in pharma
equipment/utility, computerized system etc. related.
2. Familiar with GMP, GAMP and FDA relevant requirement to
3. Enough know-how on pharma equipment, utilities and computerized
4. Fluent speaking and written in English.
5. Strong capability to work under pressure;
6. Mature, self-motivated, accountable and loyalty;
Functional Area: [sap_fa_2]
Entry Level: 5