Kerja Sepenuh Masa, CSV Engineer di No Deviation - Maukerja

Position Overview

We are seeking a CSV Engineer to support the validation of Emerson DeltaV automation systems in a pharmaceutical and biopharmaceutical manufacturing environment. Responsibilities include reviewing URS, functional and design specifications, drafting and executing test scripts for batch recipes, control logic, interlocks, alarms and sequences, supporting FAT, SAT, IQ and OQ activities, investigating discrepancies, maintaining requirements traceability, and preparing validation summary reports in compliance with GMP and GAMP 5. The successful candidate will hold a degree in Engineering, Automation, Computer Science or a related discipline, with experience in computer system validation and in drafting and executing protocols for automation systems. Familiarity with DeltaV DCS, batch recipes and control modules is preferred, as is knowledge of 21 CFR Part 11 and EU GMP Annex 11. Strong documentation and troubleshooting skills, and the ability to work independently and collaborate with cross-functional teams, are essential.

Key Responsibilities

• Develop and execute Computer System Validation (CSV) protocols for Emerson DeltaV automation systems.
• Draft detailed test scripts to validate DeltaV batch recipes, automation sequences, control logic, and system configurations.
• Review User Requirement Specifications (URS), Functional Specifications (FS), and Design Specifications (DS) to develop comprehensive validation test cases.
• Verify DeltaV batch recipes, including unit procedures, operations, phases, and recipe parameters.
• Develop test scenarios to verify automation control logic, interlocks, permissives, alarms, setpoints, and process sequences.
• Perform positive and negative testing to ensure automation systems function according to approved specifications.
• Review DeltaV control modules, equipment modules, and automation configurations to identify appropriate testing requirements.
• Support Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ), and Operational Qualification (OQ) activities.
• Execute validation protocols, document test results, and ensure appropriate evidence is captured.
• Investigate test discrepancies, document deviations, and coordinate with Automation Engineers to resolve identified issues.
• Maintain requirements traceability between functional specifications, validation protocols, and test results.
• Prepare validation documentation and summary reports in accordance with GMP requirements.
• Collaborate with Automation, Process Engineering, Manufacturing, Quality Assurance, and Validation teams to ensure successful system validation.
• Ensure validation activities comply with GMP, GAMP 5, and applicable regulatory requirements.
  
  
  

Required Qualifications

• Bachelor's degree in Engineering, Automation, Computer Science, Chemical Engineering, or a related discipline.
• Experience in Computer System Validation (CSV) within pharmaceutical or biopharmaceutical manufacturing environments.
• Experience drafting and executing validation protocols for automation systems.
• Familiarity with Emerson DeltaV Distributed Control Systems (DCS).
• Understanding of DeltaV batch recipes, control modules, equipment modules, and automation sequences.
• Ability to interpret functional specifications, automation logic, and process control sequences to develop detailed test scripts.
• Experience with FAT, SAT, IQ, and OQ activities.
• Strong technical documentation, analytical, and troubleshooting skills.
• Ability to work independently and collaborate effectively with cross-functional engineering teams.
• Experience with DeltaV recipe testing and automation logic validation in GMP manufacturing environments will be advantageous.
• Knowledge of GAMP 5, 21 CFR Part 11, and EU GMP Annex 11 will be advantageous.
  
  
  

Why join us?

• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.
  
  
  

How To Apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.