Validation Specialist

Collects relevant documents (i.e. Functional and Design Specifications, Draft and Design Drawings) from Design and Project Engineer and counterchecks each with User Requirement Specifications (URS) or As-Ordered Specifications (AOS)
- Provides end-user perspective to engineers to aid in design to satisfy customer requirements
- Attends the Design Qualification (DQ) upon request by the client and communicates with Project Engineer to align client specifications and factory design
- Creates and updates Validation Traceability Matrix (VTM) based on URS or AOS and design reviews
- Authors Factory Acceptance Test (FAT) and Installation Qualification and Operational Qualification (IQ&OQ) protocol
- Coordinates with the team to prepare pre-requisite instruments, certificates, material safety data sheets, test reports, FAT/IQ&OQ schedule, and other necessary documentation prior to FAT/IQ&OQ execution
- Coordinates with purchasing, or contacts the supplier, for documents on their respective products
- Monitors progress of FAT and IQ&OQ
- Performs miscellaneous validation activities
- Drafts ad hoc documents as required by the client for complete documentation
- Analyze equipment designs and develop plans and programs for validation and qualification studies
- Author and implement qualification protocols and standard procedures to execute validation of pharmaceutical equipment
- Execute testing based on protocols

**Competency Requirement**:

- Preferably have a degree in Biology, Pharmacy, Biomedical Engineering or any relevant life sciences course
- At least one (1) year of work experience. Fresh graduates are welcome to apply.
- Knowledgeable and/or experience in pharmaceutical validation, equipment validation, quality system implementation, and international pharmaceutical and biopharmaceutical regulations and standards
- Experience in CSV (computerized software validation) dan GMP is a plus
- With commendable technical writing skills, computer literacy, and English language proficiency
- Highly intuitive, analytical, focused, driven, and can work under great pressure
- Willing to work in a multicultural and diverse working environment
- Willing to travel locally and overseas for site acceptance testing and qualification activities

Ability to commute/relocate:

- Batam: Reliably commute or planning to relocate before starting work (preferred)

**Education**:

- S1 (preferred)

**Experience**:

- Medical Equipment Validation: 1 year (preferred)

**Language**:

- English (preferred)

Willingness to travel:

- 50% (preferred)