Validation Engineer
Becton Dickinson
Validation Engineer
Job Description
Job Description Summary
Conduct Validations on all e-DHR related activitiesJob Description
P3-14201
- Validation Planning & Execution
- Develop and execute validation protocols (IQ/OQ/PQ) for eDHR systems and related equipment.
- Ensure validation activities meet regulatory standards such as FDA 21 CFR Part 11 and ISO 13485.
- Conduct performance testing and document results to confirm system functionality and reliability.
- System Compliance & Quality Assurance
- Ensure eDHR systems comply with internal quality standards and external regulations.
- Collaborate with Quality Assurance teams to align validation efforts with broader quality goals.
- Participate in audits and provide documentation to support compliance.
- Process & Data Integrity
- Validate that eDHR systems accurately capture and store production data in real-time.
- Monitor data integrity across the manufacturing lifecycle—from raw materials to finished goods.
- Ensure traceability and error-proofing mechanisms are functioning as intended.
- Documentation & Reporting
- Author and maintain validation documentation, including protocols, reports, and SOPs.
- Record and analyze test data to identify anomalies and ensure systems meet specifications.
- Prepare detailed reports for internal review and regulatory submissions.
- Cross-Functional Collaboration
- Work with IT, OT, manufacturing, and quality teams to coordinate validation activities.
- Support changing control processes and ensure validated state is maintained during updates.
- Train and mentor team members on validation procedures and compliance requirements
Qualifications:
- Bachelor’s degree in biomedical engineering, Quality Assurance, Engineering, or Information Technology.
- Hands-on experience with eDHR systems, MES platforms (preferably Apriso), and digital manufacturing environments.
- Experience developing and executing validation protocols (IQ/OQ/PQ) for software systems and equipment.
- Strong understanding of computer system validation (CSV) principles and risk-based validation approaches.
- Skilled in performance testing, data analysis, and reporting to confirm system reliability and compliance.
- Proven ability to ensure system compliance with internal quality standards and external regulatory requirements.
- Knowledge of data integrity, error-proofing, and traceability mechanisms in manufacturing systems.
- Proficient in authoring and maintaining validation documentation, including protocols, SOPs, and test reports.
- Ability to analyze test data, identify anomalies, and ensure systems meet defined specifications.
- Experience preparing regulatory submission documents and internal review reports.
- Cross-Functional Collaboration
- Collaboration skills to work with IT, OT, Manufacturing, and Quality teams.
- Experience supporting change control processes and maintaining validated states during system updates
Required Skills
Optional Skills
.
Primary Work Location
MYS Kedah - Bard Kulim (Malaysia)Additional Locations
Work Shift
MY3 Normal 8a-4.45p Group 26 (Malaysia)Locations
- Kulim, Kedah, Malaysia
Salary
Estimated Salary Rangemedium confidence
72,000 - 144,000 MYR / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- proficiency in authoring and maintaining validation documentationintermediate
- experience with eDHR systemsintermediate
- experience with MES platformsintermediate
- experience developing and executing validation protocols (IQ/OQ/PQ)intermediate
- understanding of computer system validation (CSV) principlesintermediate
- skilled in performance testingintermediate
- skilled in data analysisintermediate
- skilled in reportingintermediate
- knowledge of data integrityintermediate
- knowledge of error-proofingintermediate
- knowledge of traceability mechanismsintermediate
- ability to analyze test dataintermediate
- experience preparing regulatory submission documentsintermediate
- collaboration skills to work with IT, OT, Manufacturing, and Quality teamsintermediate
- experience supporting change control processesintermediate
Required Qualifications
- Bachelor’s degree in biomedical engineering, Quality Assurance, Engineering, or Information Technology. (degree in biomedical engineering)
- Hands-on experience with eDHR systems, MES platforms (preferably Apriso), and digital manufacturing environments. (experience)
- Experience developing and executing validation protocols (IQ/OQ/PQ) for software systems and equipment. (experience)
- Strong understanding of computer system validation (CSV) principles and risk-based validation approaches. (experience)
- Skilled in performance testing, data analysis, and reporting to confirm system reliability and compliance. (experience)
- Proven ability to ensure system compliance with internal quality standards and external regulatory requirements. (experience)
- Knowledge of data integrity, error-proofing, and traceability mechanisms in manufacturing systems. (experience)
- Proficient in authoring and maintaining validation documentation, including protocols, SOPs, and test reports. (experience)
- Ability to analyze test data, identify anomalies, and ensure systems meet defined specifications. (experience)
- Experience preparing regulatory submission documents and internal review reports. (experience)
- Cross-Functional Collaboration (experience)
- Collaboration skills to work with IT, OT, Manufacturing, and Quality teams. (experience)
- Experience supporting change control processes and maintaining validated states during system updates (experience)
Responsibilities
- Develop and execute validation protocols (IQ/OQ/PQ) for eDHR systems and related equipment.
- Ensure validation activities meet regulatory standards such as FDA 21 CFR Part 11 and ISO 13485.
- Conduct performance testing and document results to confirm system functionality and reliability.
- Ensure eDHR systems comply with internal quality standards and external regulations.
- Collaborate with Quality Assurance teams to align validation efforts with broader quality goals.
- Participate in audits and provide documentation to support compliance.
- Validate that eDHR systems accurately capture and store production data in real-time.
- Monitor data integrity across the manufacturing lifecycle—from raw materials to finished goods.
- Ensure traceability and error-proofing mechanisms are functioning as intended.
- Author and maintain validation documentation, including protocols, reports, and SOPs.
- Record and analyze test data to identify anomalies and ensure systems meet specifications.
- Prepare detailed reports for internal review and regulatory submissions.
- Work with IT, OT, manufacturing, and quality teams to coordinate validation activities.
- Support changing control processes and ensure validated state is maintained during updates.
- Train and mentor team members on validation procedures and compliance requirements
Tags & Categories
Validation Engineer
Becton Dickinson
Validation Engineer
Job Description
Job Description Summary
Conduct Validations on all e-DHR related activitiesJob Description
P3-14201
- Validation Planning & Execution
- Develop and execute validation protocols (IQ/OQ/PQ) for eDHR systems and related equipment.
- Ensure validation activities meet regulatory standards such as FDA 21 CFR Part 11 and ISO 13485.
- Conduct performance testing and document results to confirm system functionality and reliability.
- System Compliance & Quality Assurance
- Ensure eDHR systems comply with internal quality standards and external regulations.
- Collaborate with Quality Assurance teams to align validation efforts with broader quality goals.
- Participate in audits and provide documentation to support compliance.
- Process & Data Integrity
- Validate that eDHR systems accurately capture and store production data in real-time.
- Monitor data integrity across the manufacturing lifecycle—from raw materials to finished goods.
- Ensure traceability and error-proofing mechanisms are functioning as intended.
- Documentation & Reporting
- Author and maintain validation documentation, including protocols, reports, and SOPs.
- Record and analyze test data to identify anomalies and ensure systems meet specifications.
- Prepare detailed reports for internal review and regulatory submissions.
- Cross-Functional Collaboration
- Work with IT, OT, manufacturing, and quality teams to coordinate validation activities.
- Support changing control processes and ensure validated state is maintained during updates.
- Train and mentor team members on validation procedures and compliance requirements
Qualifications:
- Bachelor’s degree in biomedical engineering, Quality Assurance, Engineering, or Information Technology.
- Hands-on experience with eDHR systems, MES platforms (preferably Apriso), and digital manufacturing environments.
- Experience developing and executing validation protocols (IQ/OQ/PQ) for software systems and equipment.
- Strong understanding of computer system validation (CSV) principles and risk-based validation approaches.
- Skilled in performance testing, data analysis, and reporting to confirm system reliability and compliance.
- Proven ability to ensure system compliance with internal quality standards and external regulatory requirements.
- Knowledge of data integrity, error-proofing, and traceability mechanisms in manufacturing systems.
- Proficient in authoring and maintaining validation documentation, including protocols, SOPs, and test reports.
- Ability to analyze test data, identify anomalies, and ensure systems meet defined specifications.
- Experience preparing regulatory submission documents and internal review reports.
- Cross-Functional Collaboration
- Collaboration skills to work with IT, OT, Manufacturing, and Quality teams.
- Experience supporting change control processes and maintaining validated states during system updates
Required Skills
Optional Skills
.
Primary Work Location
MYS Kedah - Bard Kulim (Malaysia)Additional Locations
Work Shift
MY3 Normal 8a-4.45p Group 26 (Malaysia)Locations
- Kulim, Kedah, Malaysia
Salary
Estimated Salary Rangemedium confidence
72,000 - 144,000 MYR / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- proficiency in authoring and maintaining validation documentationintermediate
- experience with eDHR systemsintermediate
- experience with MES platformsintermediate
- experience developing and executing validation protocols (IQ/OQ/PQ)intermediate
- understanding of computer system validation (CSV) principlesintermediate
- skilled in performance testingintermediate
- skilled in data analysisintermediate
- skilled in reportingintermediate
- knowledge of data integrityintermediate
- knowledge of error-proofingintermediate
- knowledge of traceability mechanismsintermediate
- ability to analyze test dataintermediate
- experience preparing regulatory submission documentsintermediate
- collaboration skills to work with IT, OT, Manufacturing, and Quality teamsintermediate
- experience supporting change control processesintermediate
Required Qualifications
- Bachelor’s degree in biomedical engineering, Quality Assurance, Engineering, or Information Technology. (degree in biomedical engineering)
- Hands-on experience with eDHR systems, MES platforms (preferably Apriso), and digital manufacturing environments. (experience)
- Experience developing and executing validation protocols (IQ/OQ/PQ) for software systems and equipment. (experience)
- Strong understanding of computer system validation (CSV) principles and risk-based validation approaches. (experience)
- Skilled in performance testing, data analysis, and reporting to confirm system reliability and compliance. (experience)
- Proven ability to ensure system compliance with internal quality standards and external regulatory requirements. (experience)
- Knowledge of data integrity, error-proofing, and traceability mechanisms in manufacturing systems. (experience)
- Proficient in authoring and maintaining validation documentation, including protocols, SOPs, and test reports. (experience)
- Ability to analyze test data, identify anomalies, and ensure systems meet defined specifications. (experience)
- Experience preparing regulatory submission documents and internal review reports. (experience)
- Cross-Functional Collaboration (experience)
- Collaboration skills to work with IT, OT, Manufacturing, and Quality teams. (experience)
- Experience supporting change control processes and maintaining validated states during system updates (experience)
Responsibilities
- Develop and execute validation protocols (IQ/OQ/PQ) for eDHR systems and related equipment.
- Ensure validation activities meet regulatory standards such as FDA 21 CFR Part 11 and ISO 13485.
- Conduct performance testing and document results to confirm system functionality and reliability.
- Ensure eDHR systems comply with internal quality standards and external regulations.
- Collaborate with Quality Assurance teams to align validation efforts with broader quality goals.
- Participate in audits and provide documentation to support compliance.
- Validate that eDHR systems accurately capture and store production data in real-time.
- Monitor data integrity across the manufacturing lifecycle—from raw materials to finished goods.
- Ensure traceability and error-proofing mechanisms are functioning as intended.
- Author and maintain validation documentation, including protocols, reports, and SOPs.
- Record and analyze test data to identify anomalies and ensure systems meet specifications.
- Prepare detailed reports for internal review and regulatory submissions.
- Work with IT, OT, manufacturing, and quality teams to coordinate validation activities.
- Support changing control processes and ensure validated state is maintained during updates.
- Train and mentor team members on validation procedures and compliance requirements
Tags & Categories