Validation Engineer

5w1 month ago

PSC Biotech

Singapore, SG · Contract · S$70,000 – S$110,000

About this role

The Validation Engineer position involves managing qualification and validation activities for pharmaceutical utilities and processes. Responsibilities include WFI systems, SIP procedures, and sterilization equipment to ensure all operations meet industry guidelines and standards.

Daily work covers cleaning validation, warehouse mapping, filtration skids, mixing tanks, and washer qualification. Additional focus includes trending results through data mining and LIMS queries to monitor ongoing performance and compliance.

The role requires leading project validation activities while collaborating with cross-functional teams to plan and execute qualification tasks smoothly. Managing stakeholders and facilitating discussions supports timely delivery of project deliverables and vendor package reviews.

Participation in the site Validation Maintenance Program and support for change implementation provides ongoing involvement in lifecycle documentation and deviation investigations across the facility.

Requirements

10 years and above of experience for a senior role
3-5 years of experience in mid-level role
0-3 years of experience in a junior role

Responsibilities

Perform RQ of Utilities (WFI)
Conduct Process RQs including SIP, Bulk Sterilization, and Autoclave
Execute cleaning validation, warehouse mapping, and equipment qualifications
Develop, review, and approve validation lifecycle documents and protocols/reports
Lead project validation activities and provide guidance to junior engineers
Review Turnover / Vendor Packages to support qualification activities
Manage qualification execution and lead validation deviation investigations
Participate in site Validation Maintenance Program and support Change Implementation