Validation Engineer
PSC Biotech
Contract
On-site
Boon Lay Way, South West, Singapore
Healthcare
- RQ of Utilities (WFI)<\/span><\/span><\/span><\/span><\/span><\/span>
<\/li>- ā<\/span><\/span><\/span>Process RQs (SIP, Bulk Sterilization, Autoclave)<\/span><\/span><\/span>
<\/span><\/span><\/span><\/span><\/span><\/li>- Cleaning validation<\/span><\/span><\/span><\/span>
<\/span><\/span><\/span><\/li>- Warehouse mapping<\/span><\/span><\/span><\/span>
<\/span><\/span><\/span><\/li>- Filtration skids<\/span><\/span><\/span><\/span>
<\/span><\/span><\/span><\/li>- Mixing tank<\/span><\/span><\/span><\/span>
<\/span><\/span><\/span><\/li>- Washer qualification<\/span><\/span><\/span>
<\/span><\/span><\/span><\/span><\/li>- Trending of Results<\/span><\/span><\/span>
<\/span><\/span><\/span><\/span><\/li>- Data mining<\/span><\/span><\/span>
<\/span><\/span><\/span><\/span><\/li>- LIMS queries<\/span><\/span><\/span>
<\/span><\/span><\/span><\/span><\/li>- Develop, review and/or approve validation lifecycle document and protocols/reports in accordance with relevant policies, standards, procedures and guidelines, and completed in a timely fashion.<\/span><\/span><\/span>
<\/span><\/span><\/span><\/span><\/li>- Lead project validation activities, and provide basic guidance and direction to junior project engineer as required.<\/span><\/span><\/span>
<\/span><\/span><\/span><\/span><\/li>- Review Turnover / Vendor Packages as part of the project deliverables to support qualification activities.<\/span><\/span><\/span>
<\/span><\/span><\/span><\/span><\/li>- Manage qualification execution and lead validation deviation investigation encountered in qualification<\/span><\/span><\/span><\/span>
<\/li>- Collaborate with multi functions to arrange, plan and ensure smooth running of the qualification activities.<\/span><\/span><\/span>
<\/span><\/span><\/span><\/span><\/li>- Able to manage cross function stakeholders, and to lead / facilitate meeting and discussion relevant to project qualification/ validation activities.<\/span><\/span><\/span>
<\/span><\/span><\/span><\/span><\/li>- Participate in site Validation Maintenance Program.<\/span><\/span><\/span>
<\/span><\/span><\/span><\/span><\/li>- Support Change Implementation on site.<\/span><\/span><\/span>
<\/span><\/span><\/span><\/span><\/li>- Any other tasks as and when assigned by Supervisor or Project Lead.<\/span><\/span><\/span><\/span>
<\/span><\/li><\/ul>
<\/div><\/span>Requirements<\/h3>
- Preferably 10 years and above of experience for a senior role<\/span><\/span><\/span><\/span>
<\/span><\/span><\/li>- 3 -5 years of experience in mid -level role<\/span><\/span><\/span><\/span>
<\/span><\/span><\/li>- 0 -3 years of experience in a junior role<\/span><\/span><\/span><\/span>
<\/span><\/span><\/li><\/ul>
<\/div><\/span> - 3 -5 years of experience in mid -level role<\/span><\/span><\/span><\/span>
- ā<\/span><\/span><\/span>Process RQs (SIP, Bulk Sterilization, Autoclave)<\/span><\/span><\/span>