Validation Engineer - Bintan Regency - Esco

Deskripsi

Esco Lifesciences Group is improving lives through science Headquartered in Singapore, expanded globally with factories and offices in 43 locations around the world, Esco is building a synergistic ecosystem of life science tools, diagnostics, therapies, and technologies to improve human lives.

With nearly 50 years of history and a strong foundation in Singapore, Esco is a dynamic, fast-growing, mid-sized multinational organization that bridges East and West. We offer a diverse, inclusive, and globally connected environment where you'll collaborate with top experts and visionary clients worldwide. As we accelerate our global expansion, you'll have the unique opportunity to grow your career in tandem with the company, driving innovation and shaping a healthier, more equitable, and resilient future.

Job Title: Validation Specialist

Location: Bintan, Indonesia

Direct Manager: Operations Manager

Key Responsibilities:

• 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.
• Employ risk management and validation gap analysis to mitigate and apply remediation measures to existing pharmaceutical process deviations.

Key Requirements:

• Bachelor's degree in Pharmacy, Biomedical/Bioprocess/Chemical/Instrumentation Engineering, Biotechnology or other relevant fields.
• Minimum 1 (one) year of work experience in Quality Assurance field. 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.