- Understand development of Computer System Validation (CSV) and equipment specifications and executing Computer System Validation, System Development Life Cycle (SDLC), and other pharmaceutical equipment/system commissioning/validation such as installation qualification (IQ), operational qualification (OQ), performance qualification (PQ) protocols in accordance with Good Engineering Practices, GAMP, local SOPs, industry best practices and other industry related guidance documents.
- Assess the impact of changes to cGMP equipment/systems and methods and establish the applicable Validation Plan to ensure the validated status following changes.
- Experience in technical writing and report generation of testing methodologies of automated systems.
- Expertise in evaluating validation protocols and summary reports.
- Strong understanding of Testing and Software Development Lifecycle and QA methodologies.
- Responsible for being a quality contact and primary Subject Matter Expert (SME) for complex deviations for systems, processes, and equipment related to engineering, facilities, automation, manufacturing, and validation.
- Support and review complex deviation investigations related to manufacturing process equipment, utilities, automation, validation, and engineering.
- Work closely with Operations, Facilities, Manufacturing, Automation, Validation, and Engineering to resolve open issues resulting from equipment failures, issues, and deviation record reviews.
- Lead the QA review and assessments of deviations; includes performing risk assessments, leading root cause analysis investigations, tracking, follow-up, close out, and reporting/trending.
- Bachelor Degree in any engineering field
- Minimum 1 year of validation experience and demonstrated experience in cGMP automation/computerized systems, quality, and compliance areas in the pharmaceutical industry.
- Thorough understanding of industry standards and best practices for computer system validation.
- Extensive experience with validation of equipment controlled by PLCs, SCADAs, BAS/BMS systems, DeltaV, and other typical automated system platforms preferred.
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Computer System Validation - Singapore - RANDSTAD PTE. LIMITED
Description
Roles & ResponsibilitiesComputer System Validation (CSV) Engineer
12 months contract
Our client is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
Responsibilities:
Job requirements:
Reg No: R
EA License no: 94C3609
Tell employers what skills you havePharmaceutical Industry
Technical Writing
Healthcare
Global Health
GMP
GAMP
Root Cause Analysis
SDLC
Wireless
Protocol
Imagination
Computer System Validation
LIMS
Manufacturing
Software Development
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