- The Computer System Validation (CSV) Specialist role is a global enterprise role. The Specialist manages the validation deliverables for computer systems to support product quality and compliance with internal/external standards, procedures, and regulations.
- The role requires applying specialized validation and regulatory knowledge mainly in the Medical Devices manufacturing area.
- The role's responsibilities require a high level of independence, proactiveness, ownership, accountability, and communication (written/verbal) with diverse and global stakeholders and teams.
- The role also requires deep analysis, critical thinking, judgment calls, prioritization, continuous learning, and supporting/training others.
- Develops and executes validation plans, deliverables, and procedures that are consistent with the Celestica standards and the industry validation frameworks and principles (ex: GAMP 5, FDA CSA).
- Applies regulatory requirements and standards to systems, processes, and projects (ex: FDA Parts 11/820, EU GMP/MDR, ISO 9001/13485).
- Supports validation projects that use Software Development Life Cycle (SDLC) methodologies (ex: waterfall, agile). Creates, executes, and reviews validation deliverables within an SDLC process.
- Independently manages the CSV workstream deliverables of a project or change requests. Seeks support from management, other team members, or Subject Matter Experts (SMEs) as needed. Supports others in understanding and applying validation procedures.
- Analyzes a system's intended use, business/technical processes, data flows, requirements, design, suppliers, and/or operations to identify GxP impacts and risks for projects and change requests. Recommends mitigations and approaches to handle GxP risks and impacts.
- Creates risk-based validation plans and reports for diverse business/technical systems, projects, and change requests. Creates and scales the rigor of validation deliverables based on the risk assessments.
- Analyzes and suggests improvements to operational change controls and configuration management procedures for GxP systems.
- Creates, maintains, and updates documents/records in accordance with regulatory standards and company procedures. Recommends records management approaches and improvements for GxP systems and projects.
- Supports the administration of the CSV documentation and records system with minimal supervision.
- Reviews validation deliverables created by others for suitability, accuracy, and completeness.
- Supports the CSV deliverables of periodic reviews and internal/external audits collaborating with cross-functional teams. Identifies and reports any deviations or non-conformance findings.
- Develops, reviews and/or revises policies, procedures, and guidelines for the CSV Program. Identifies gaps and improvement areas in the CSV Program and proposes solutions to address them.
- Strong understanding of the main industry validation frameworks, ex: GAMP 5, FDA CSA.
- Knowledge of the regulatory requirements and standards, ex: FDA Parts 11/820, EU GMP/MDR, ISO 9001/13485
- Knowledge and familiarity with the following type of the systems is preferred, but not mandatory: Manufacturing Execution Systems (MES, ex: Siemens, Plex), Quality Management Systems (QMS, ex: EtQ), Enterprise Resource Planning (ERP, ex: SAP), Product Lifecycle Management Systems (PLM, ex: Enovia).
- Ability to continuously learn new technologies and business processes and operations willingly and proactively.
- Ability to work and think critically, independently, and proactively with minimal supervision.
- Ability to take end-to-end accountability and responsibility to drive assignments and projects to completion.
- Strong communication (written and verbal) skills in English.
- Ability to build relationships and communicate effectively with diverse and global business/technical stakeholders and teams.
- Strong project and team management and collaboration skills.
- 3 to 5 years of CSV, QA, and/or Business/System Analysis of experience.
- Preferred, but not mandatory, experience in the Medical Device manufacturing industry, other Health Tech regulated industries such as Pharmaceuticals, and/or the electronics manufacturing industry.
- Bachelor degree in computer science, engineering (computer, industrial, mechanical, electrical), business/information system management, or equivalent.
- Training in validation methodologies, technologies, and process control computer systems.
-
EHS Executive
5 hours ago
SA TEAM ENGINEERING SDN BHD Senai, Malaysia**Requirement/Qualification**: · - Degree/ Diploma in Environmental, Safety & Health or equivalent. · - Experience in Safety, Health & Environment field. · - Must be registered with DOSH and possess valid YELLOW BOOK. · - Good people management skills. · Job type: Permanent · **J ...
-
JOBBUILDER Senai, MalaysiaAssisting on data compilation on bi-yearly vendor reassessment for IMS compliance for June and December. · - Assisting to get quotations from vendor. · - Matching documents to be attached to invoice and verifying before submission to finance. · - Maintain proper filing system for ...
-
Asset Manager
1 day ago
Invenio Potential Senai, MalaysiaResponsibilities: · - To carry out effective supervision on the day-to-day operation and administration of the properties including building and ground maintenance. · - Responsible for identifying and drawing up specifications, obtaining quotations for materials, preparing summar ...
-
Security Guard
6 days ago
SEIKO DENKI (M) SDN BHD Senai, Malaysia**Responsibilities**: · Monitor and authorize the entrance and departure of employees, visitors, and other persons to maintain the security of the premises. · Patrol assigned areas regularly to prevent and detect signs of intrusion, vandalism, theft, or other criminal activities. ...
-
Machining Specialist
1 week ago
ZF Senai, Malaysia**What's Next? Join ZF**: · ZF is a global technology company supplying systems for passenger cars, commercial vehicles and industrial technology, enabling the next generation of mobility. · ZF allows vehicles to see, think and act. In the four technology domains of Vehicle Motio ...
-
J - Procurement Clerk 1 Year Contract
6 days ago
AGENSI PEKERJAAN THE SUPREME HR ADVISORY SDN. BHD. Senai, MalaysiaJob Descriptions: · - Assisting on data compilation on bi-yearly vendor reassessment for IMS compliance for June and December. · - Assisting to get quotations from vendor. · - Matching documents to be attached to invoice and verifying before submission to finance. · - Maintain pr ...
-
Procurement Assistant Seelong
6 days ago
JOBBUILDER Senai, Malaysia**Job Descriptions**: · **(E6421L)** · - Assisting on data compilation on bi-yearly vendor reassessment for IMS compliance for June and December. · - Assisting to get quotations from vendor. · - Matching documents to be attached to invoice and verifying before submission to finan ...
-
I-procurement Clerk
6 days ago
AGENSI PEKERJAAN THE SUPREME HR ADVISORY SDN. BHD. Senai, Malaysia**5 Working Days**: · - **Career Advancement Opportunity**: · - **Based in Jalan Seelong,Senai** · **Interested applicants can also send your updated resume and allow our Consultant to match you with our Clients.** · **Job Scope**: · - Assisting on data compilation on bi-yearly v ...
-
Materials Program Management
3 days ago
Celestica Senai, MalaysiaReq ID: 120716 · Remote Position: No · Region: Asia · Country: Malaysia · State/Province: Johor · City: Senai · **Detailed Description**: · Performs tasks such as, but not limited to, the following: · - Interfaces with Business Office, Production, Procurement, Planning and custom ...
-
QA Executive
5 hours ago
GC PACKAGING SDN BHD Kulai, Malaysia* Creates and implements company quality standards. · - Accomplishes quality assurance objectives by monitoring, reviewing, and enforcing policies and procedures. · - Trains and motivates employees to ensure that quality standards are met. · - Achieves quality assurance operation ...
-
QA Assistant Manager
3 days ago
LEE SOON SENG PLASTIC INDUSTRIES SDN. BHD. Kulai, Malaysia_The QA Assistant Manager assists head of department with overall development, implementation, and maintenance of the organization's Quality Assurance Program, Quality Management System (QMS) and Food Safety Management System (FSSC). Continuously achieve QA department KPIs._ · - ...
-
Site Safety Supervisor
5 hours ago
ASAS BALI CONSTRUCTION SDN BHD Kulai, Malaysia**SITE SAFETY SUPERVISOR** · **Site Location: Sedenak,Kulai,JOHOR.** · **Job Overview**: · **Responsibilities**: · 1. Safety Compliance: · Ensure strict adherence to all relevant safety regulations, standards and guidelines. · Conduct regular safety inspections and audits to iden ...
-
Cost Management Manager
4 days ago
Agensi Pekerjaan GMRecruitment Sdn Bhd Kulai, Malaysia**Prepare and monitor CAPEX budgets, track changes, and adjust budget projections accordingly.**: · - Provide forecasts, cash flow analysis, and procurement/cost reports. · - Conduct feasibility studies and support Change Management process for the project. · - **Price/forecast c ...
-
Cost Management Manager
1 day ago
Agensi Pekerjaan GMRecruitment Sdn Bhd Kulai, Malaysia**Prepare and monitor CAPEX budgets, track changes, and adjust budget projections accordingly.**: · - Provide forecasts, cash flow analysis, and procurement/cost reports. · - Conduct feasibility studies and support Change Management process for the project. · - **Price/forecast c ...
-
JOBBUILDER Tampoi, Malaysia**Responsibilities**: · - Process and manage Purchase Orders to manufacturers/suppliers, and ensure the accuracy of purchase information and details, including pricing, quantities, and specifications. · - Verify and validate purchase orders to minimize errors and discrepancies. · ...
-
Branch in Charge
1 day ago
Ria Money Transfer Tampoi, Malaysia**Being part of our retail team means that**: · - You enjoy working in a customer facing role, · - You are driven by providing excellent customer services, · - You are confident in handling our customer's money in a fast-paced environment, · - You appreciate diversity and have th ...
-
Data Entry Clerk
2 days ago
CAPE MANUFACTURING (M) SDN BHD Tebrau, Malaysia1) Inputting data into Excel the ERP system. · 2) Create spreadsheets to track important customer information and orders. · 3) Verifying and validating data. · 4) Able to use Microsoft Word, Excel. · 5) Generate report. · 6) At least 1 year experience in ERP System. · 7) Can work ...
-
Business Analyst
5 hours ago
EPS Ventures Sdn Bhd Tebrau, Malaysia**Responsibilities**: · 1. Requirement Gathering: Gather and document business requirements from stakeholders, ensuring clarity and completeness. · 2. Analysis: Analyse business processes and systems to identify areas for improvement and optimization. · 3. Documentation: Create d ...
-
Wira Security Services Sdn Bhd Gelang Patah, Malaysia**CUSTOMER SERVICE OFFICER** · JOHOR BAHRU SERVICE CENTRE · AUTOPASS COLLECTION CENTRE · **JOB SCOPE** · - ASSIST MOTORIST IN CARD COLLECTION/ACTIVATION AND RECORD ALL THE NECESSARY DETAILS BEFORE ISSUING THE CARD · - ASSIST MOTORIST IN VEP APPLICATION(ONLINE APPLICATION) · - HAN ...
-
IT Officer
2 days ago
Olam Food Ingredients (ofi) Gelang Patah, Malaysia**Job Summary** · **Main Responsibilities** · - Responsible to abide Corporate IT Policies and security. · - Properly administer on company's IT resources, IT Spare Parts and IT asset. · - Maintain computer hardware, software, systems, networks, communication, CCTV, Door Access, ...
08 - Specialist, Computer System Validation - Senai, Malaysia - Celestica Electronics (S) Pte Ltd
Description
Summary
Detailed Description
Below are the typical but not exhaustive tasks and deliverables:
Knowledge/Skills/Competencies
Typical Experience
Typical Education
Notes
This job description is not intended to be an exhaustive list of all duties and responsibilities of the position. Employees are held accountable for all duties of the job. Job duties and the % of time identified for any function are subject to change at any time.
