Validation Engineer II
AbbVie
Validation Engineer II
Job Description
Purpose Statement: Ensures appropriate policies and standards are applied and that engineering activities have robust quality oversight.Responsible for adhering to Validation Plans for Process Equipment, Facility and Utility, Lab equipment and Shipping Validation for initial and periodic evaluation.Coordinate validation activities actively, ensure flawless execution of protocols and proceduresSupport on topics related to Qualification during inspections and auditsResponsible to analyze trends, identify and resolve issues that potentially impact validated status of E/F/U systems.Responsibilities: Adhere to Validation plan and procedure related to E/F/U systems Qualification, Lab equipment Qualification and shipping Validation.Adhere to continually evolving GMP regulations and industry practices with particular relevance to qualification of E/F/U systems, lab equipment and shipping validation and contribute to the implementation of plans to address any gapsAdhere to appropriate validation master plans and validation execution plans related to E/F/U system, Lab equipment and Shipping validation in the AbbVie Operations Campus in Tuas, Singapore comprising of both API and Biologics manufacturing facilities.Generate and execute protocols for initial and subsequent re-qualification programs related to E/F/U systems, Lab system and Shipping validation.Work with cross functional team in providing Quality oversight in E/F/U and lab equipmentQualification related procedure and ensure compliance to GMP standards and AbbVie policies and proceduresActively engaged in developing specifications for E/F/U systems and assist in Commissioning (FAT / SAT etc., not limited) of related system as part of the new build-outsCollaborate with other AbbVie sites within the network to ensure a harmonized approach to Qualification.Act as one of the key focal points for Qualification and Validation (E/F/U, Lab equipment & Shipping validation) topics such as deviations, change management, investigations, CAPA identification and closure and as a Subject Matter Expert, front regulatory audits, when needed.
Locations
- Singapore, sg
Salary
Salary not disclosed
Estimated Salary Rangemedium confidence
80,000 - 120,000 USD / yearly
Source: AI estimated from job description
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Validation planning and executionintermediate
- GMP compliance and regulatory knowledgeintermediate
- Protocol generation and executionintermediate
- Quality oversight and cross-functional collaborationintermediate
- Trend analysis and issue resolutionintermediate
- Commissioning and specification developmentintermediate
- Audit and inspection supportintermediate
- Change management and CAPA handlingintermediate
Required Qualifications
- Adherence to continually evolving GMP regulations and industry practices with particular relevance to qualification of E/F/U systems, lab equipment and shipping validation (experience)
- Experience in validation master plans and execution plans for E/F/U systems, lab equipment, and shipping validation in API and Biologics manufacturing facilities (experience)
- Knowledge of commissioning processes including FAT/SAT for E/F/U systems (experience)
- Ability to act as Subject Matter Expert in regulatory audits, deviations, change management, investigations, and CAPA (experience)
Responsibilities
- Adhere to Validation plans and procedures for Process Equipment, Facility and Utility, Lab equipment, and Shipping Validation for initial and periodic evaluation
- Coordinate validation activities and ensure flawless execution of protocols and procedures
- Provide support on Qualification topics during inspections and audits
- Analyze trends, identify and resolve issues impacting validated status of E/F/U systems
- Generate and execute protocols for initial and re-qualification programs related to E/F/U systems, Lab systems, and Shipping validation
- Work with cross-functional teams to provide Quality oversight in E/F/U and lab equipment qualification, ensuring compliance to GMP standards and AbbVie policies
- Develop specifications for E/F/U systems and assist in commissioning (FAT/SAT) as part of new build-outs
- Collaborate with other AbbVie sites to ensure harmonized approach to Qualification
- Act as key focal point for Qualification and Validation topics including deviations, change management, investigations, CAPA, and front regulatory audits
Tags & Categories
Validation Engineer II
AbbVie
Validation Engineer II
Job Description
Purpose Statement: Ensures appropriate policies and standards are applied and that engineering activities have robust quality oversight.Responsible for adhering to Validation Plans for Process Equipment, Facility and Utility, Lab equipment and Shipping Validation for initial and periodic evaluation.Coordinate validation activities actively, ensure flawless execution of protocols and proceduresSupport on topics related to Qualification during inspections and auditsResponsible to analyze trends, identify and resolve issues that potentially impact validated status of E/F/U systems.Responsibilities: Adhere to Validation plan and procedure related to E/F/U systems Qualification, Lab equipment Qualification and shipping Validation.Adhere to continually evolving GMP regulations and industry practices with particular relevance to qualification of E/F/U systems, lab equipment and shipping validation and contribute to the implementation of plans to address any gapsAdhere to appropriate validation master plans and validation execution plans related to E/F/U system, Lab equipment and Shipping validation in the AbbVie Operations Campus in Tuas, Singapore comprising of both API and Biologics manufacturing facilities.Generate and execute protocols for initial and subsequent re-qualification programs related to E/F/U systems, Lab system and Shipping validation.Work with cross functional team in providing Quality oversight in E/F/U and lab equipmentQualification related procedure and ensure compliance to GMP standards and AbbVie policies and proceduresActively engaged in developing specifications for E/F/U systems and assist in Commissioning (FAT / SAT etc., not limited) of related system as part of the new build-outsCollaborate with other AbbVie sites within the network to ensure a harmonized approach to Qualification.Act as one of the key focal points for Qualification and Validation (E/F/U, Lab equipment & Shipping validation) topics such as deviations, change management, investigations, CAPA identification and closure and as a Subject Matter Expert, front regulatory audits, when needed.
Locations
- Singapore, sg
Salary
Salary not disclosed
Estimated Salary Rangemedium confidence
80,000 - 120,000 USD / yearly
Source: AI estimated from job description
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Validation planning and executionintermediate
- GMP compliance and regulatory knowledgeintermediate
- Protocol generation and executionintermediate
- Quality oversight and cross-functional collaborationintermediate
- Trend analysis and issue resolutionintermediate
- Commissioning and specification developmentintermediate
- Audit and inspection supportintermediate
- Change management and CAPA handlingintermediate
Required Qualifications
- Adherence to continually evolving GMP regulations and industry practices with particular relevance to qualification of E/F/U systems, lab equipment and shipping validation (experience)
- Experience in validation master plans and execution plans for E/F/U systems, lab equipment, and shipping validation in API and Biologics manufacturing facilities (experience)
- Knowledge of commissioning processes including FAT/SAT for E/F/U systems (experience)
- Ability to act as Subject Matter Expert in regulatory audits, deviations, change management, investigations, and CAPA (experience)
Responsibilities
- Adhere to Validation plans and procedures for Process Equipment, Facility and Utility, Lab equipment, and Shipping Validation for initial and periodic evaluation
- Coordinate validation activities and ensure flawless execution of protocols and procedures
- Provide support on Qualification topics during inspections and audits
- Analyze trends, identify and resolve issues impacting validated status of E/F/U systems
- Generate and execute protocols for initial and re-qualification programs related to E/F/U systems, Lab systems, and Shipping validation
- Work with cross-functional teams to provide Quality oversight in E/F/U and lab equipment qualification, ensuring compliance to GMP standards and AbbVie policies
- Develop specifications for E/F/U systems and assist in commissioning (FAT/SAT) as part of new build-outs
- Collaborate with other AbbVie sites to ensure harmonized approach to Qualification
- Act as key focal point for Qualification and Validation topics including deviations, change management, investigations, CAPA, and front regulatory audits
Tags & Categories