Validation Engineer
Amgen
Validation Engineer
Job Description
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
What you will do
- Advising clients on how to meet compliance requirements using a risk-based approach
- Develop validation documentation and standard operating procedures for various GxP applications
- Develop test protocols that thoroughly test business requirements
- Provide test execution oversight and assist with deviation recommendations as required
- Work with clients to develop validation plans to ensure that, at the end of the project, the system meets GxP requirements
- Work with client business functions and subject matter experts to develop User Requirements Specification, Functional Requirements Specification, and/or Design Specifications as required
- Development of test / validation scripts based on software design and configurations
- Develop IQ/OQ scripts as required
What we expect of you
- Master’s degree with 4 - 6 years of experience in validation/regulatory or related field
- Bachelor’s degree with 6 - 8 years of experience in validation/regulatory or related field
Must-Have Skills
- Demonstrated experience with minimum of 3 to 5 years in pharmaceutical industry, focusing on Computer Systems Validations / GAMP
- Experience with regulatory agencies – FDA, EMEA, CFDA, and other regulatory agencies
- Thorough understanding of the principles of GAMP, SDLC methodologies and testing best practice
- Ability to understand existing and new business processes and requirements to ensure proper implementation and validation of systems
- Expertise with ALM testing and ALM software
- Expertise in use – Veeva (all modules – CDocs, QMS, RIM, DocuSign, etc)
- Fluent knowledge of rules and regulations: GAMP 5, 21 CFR Part 11 Compliance and CFR Part 210, 211 Compliance
- Ability to work independently, excellent problem solving and professional written communications skills
- Fluent in Microsoft Office suite Including (Excel, Power Point, Visio, Project)
- Experience with Smartsheets, Salesforce, Tableau a plus
- FDA Audit experience a plus & working with regulatory agencies
- Experience with instrument qualifications (IQ/OQ), validation plans, regulated workflows
- Excellent leadership and team management skills
- Strong transformation and change management experience
- Ability to work effectively with global, virtual teams
- Excellent analytical and troubleshooting skills
- Ability to manage multiple priorities successfully
- Strong presentation and public speaking skills
- Strong verbal and written communication skills
- High degree of initiative and self-motivation
What you can expect of us
- Competitive benefits
- Collaborative culture
- Support for professional and personal growth and well-being
- Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards
Locations
- Hyderabad, India
Salary
Salary not disclosed
Estimated Salary Rangehigh confidence
15,000 - 25,000 USD / yearly
Source: xAI estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Demonstrated experience with minimum of 3 to 5 years in pharmaceutical industry, focusing on Computer Systems Validations / GAMPintermediate
- Experience with regulatory agencies – FDA, EMEA, CFDA, and other regulatory agenciesintermediate
- Thorough understanding of the principles of GAMP, SDLC methodologies and testing best practiceintermediate
- Ability to understand existing and new business processes and requirements to ensure proper implementation and validation of systemsintermediate
- Expertise with ALM testing and ALM softwareintermediate
- Expertise in use – Veeva (all modules – CDocs, QMS, RIM, DocuSign, etc)intermediate
- Fluent knowledge of rules and regulations: GAMP 5, 21 CFR Part 11 Compliance and CFR Part 210, 211 Complianceintermediate
- Ability to work independently, excellent problem solving and professional written communications skillsintermediate
- Fluent in Microsoft Office suite Including (Excel, Power Point, Visio, Project)intermediate
- Experience with Smartsheets, Salesforce, Tableau a plusintermediate
- FDA Audit experience a plus & working with regulatory agenciesintermediate
- Experience with instrument qualifications (IQ/OQ), validation plans, regulated workflowsintermediate
- Excellent leadership and team management skillsintermediate
- Strong transformation and change management experienceintermediate
- Ability to work effectively with global, virtual teamsintermediate
- Excellent analytical and troubleshooting skillsintermediate
- Ability to manage multiple priorities successfullyintermediate
- Strong presentation and public speaking skillsintermediate
- Strong verbal and written communication skillsintermediate
- High degree of initiative and self-motivationintermediate
Required Qualifications
- Master’s degree with 4 - 6 years of experience in validation/regulatory or related field (experience)
- Bachelor’s degree with 6 - 8 years of experience in validation/regulatory or related field (experience)
Responsibilities
- Advising clients on how to meet compliance requirements using a risk-based approach
- Develop validation documentation and standard operating procedures for various GxP applications
- Develop test protocols that thoroughly test business requirements
- Provide test execution oversight and assist with deviation recommendations as required
- Work with clients to develop validation plans to ensure that, at the end of the project, the system meets GxP requirements
- Work with client business functions and subject matter experts to develop User Requirements Specification, Functional Requirements Specification, and/or Design Specifications as required
- Development of test / validation scripts based on software design and configurations
- Develop IQ/OQ scripts as required
Benefits
- general: Competitive benefits
- general: Collaborative culture
- general: Support for professional and personal growth and well-being
- general: Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards
Tags & Categories
Validation Engineer
Amgen
Validation Engineer
Job Description
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
What you will do
- Advising clients on how to meet compliance requirements using a risk-based approach
- Develop validation documentation and standard operating procedures for various GxP applications
- Develop test protocols that thoroughly test business requirements
- Provide test execution oversight and assist with deviation recommendations as required
- Work with clients to develop validation plans to ensure that, at the end of the project, the system meets GxP requirements
- Work with client business functions and subject matter experts to develop User Requirements Specification, Functional Requirements Specification, and/or Design Specifications as required
- Development of test / validation scripts based on software design and configurations
- Develop IQ/OQ scripts as required
What we expect of you
- Master’s degree with 4 - 6 years of experience in validation/regulatory or related field
- Bachelor’s degree with 6 - 8 years of experience in validation/regulatory or related field
Must-Have Skills
- Demonstrated experience with minimum of 3 to 5 years in pharmaceutical industry, focusing on Computer Systems Validations / GAMP
- Experience with regulatory agencies – FDA, EMEA, CFDA, and other regulatory agencies
- Thorough understanding of the principles of GAMP, SDLC methodologies and testing best practice
- Ability to understand existing and new business processes and requirements to ensure proper implementation and validation of systems
- Expertise with ALM testing and ALM software
- Expertise in use – Veeva (all modules – CDocs, QMS, RIM, DocuSign, etc)
- Fluent knowledge of rules and regulations: GAMP 5, 21 CFR Part 11 Compliance and CFR Part 210, 211 Compliance
- Ability to work independently, excellent problem solving and professional written communications skills
- Fluent in Microsoft Office suite Including (Excel, Power Point, Visio, Project)
- Experience with Smartsheets, Salesforce, Tableau a plus
- FDA Audit experience a plus & working with regulatory agencies
- Experience with instrument qualifications (IQ/OQ), validation plans, regulated workflows
- Excellent leadership and team management skills
- Strong transformation and change management experience
- Ability to work effectively with global, virtual teams
- Excellent analytical and troubleshooting skills
- Ability to manage multiple priorities successfully
- Strong presentation and public speaking skills
- Strong verbal and written communication skills
- High degree of initiative and self-motivation
What you can expect of us
- Competitive benefits
- Collaborative culture
- Support for professional and personal growth and well-being
- Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards
Locations
- Hyderabad, India
Salary
Salary not disclosed
Estimated Salary Rangehigh confidence
15,000 - 25,000 USD / yearly
Source: xAI estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Demonstrated experience with minimum of 3 to 5 years in pharmaceutical industry, focusing on Computer Systems Validations / GAMPintermediate
- Experience with regulatory agencies – FDA, EMEA, CFDA, and other regulatory agenciesintermediate
- Thorough understanding of the principles of GAMP, SDLC methodologies and testing best practiceintermediate
- Ability to understand existing and new business processes and requirements to ensure proper implementation and validation of systemsintermediate
- Expertise with ALM testing and ALM softwareintermediate
- Expertise in use – Veeva (all modules – CDocs, QMS, RIM, DocuSign, etc)intermediate
- Fluent knowledge of rules and regulations: GAMP 5, 21 CFR Part 11 Compliance and CFR Part 210, 211 Complianceintermediate
- Ability to work independently, excellent problem solving and professional written communications skillsintermediate
- Fluent in Microsoft Office suite Including (Excel, Power Point, Visio, Project)intermediate
- Experience with Smartsheets, Salesforce, Tableau a plusintermediate
- FDA Audit experience a plus & working with regulatory agenciesintermediate
- Experience with instrument qualifications (IQ/OQ), validation plans, regulated workflowsintermediate
- Excellent leadership and team management skillsintermediate
- Strong transformation and change management experienceintermediate
- Ability to work effectively with global, virtual teamsintermediate
- Excellent analytical and troubleshooting skillsintermediate
- Ability to manage multiple priorities successfullyintermediate
- Strong presentation and public speaking skillsintermediate
- Strong verbal and written communication skillsintermediate
- High degree of initiative and self-motivationintermediate
Required Qualifications
- Master’s degree with 4 - 6 years of experience in validation/regulatory or related field (experience)
- Bachelor’s degree with 6 - 8 years of experience in validation/regulatory or related field (experience)
Responsibilities
- Advising clients on how to meet compliance requirements using a risk-based approach
- Develop validation documentation and standard operating procedures for various GxP applications
- Develop test protocols that thoroughly test business requirements
- Provide test execution oversight and assist with deviation recommendations as required
- Work with clients to develop validation plans to ensure that, at the end of the project, the system meets GxP requirements
- Work with client business functions and subject matter experts to develop User Requirements Specification, Functional Requirements Specification, and/or Design Specifications as required
- Development of test / validation scripts based on software design and configurations
- Develop IQ/OQ scripts as required
Benefits
- general: Competitive benefits
- general: Collaborative culture
- general: Support for professional and personal growth and well-being
- general: Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards
Tags & Categories