AbbVie
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Validation Engineer III
role at
AbbVie This range is provided by AbbVie. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range
$82,500.00/yr - $157,500.00/yr Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. Job Description An engineering professional that works with project owners, subject designers/engineers and other project team members to plan, and complete tasks associated with commissioning, qualification and validation of new and modified equipment, facilities, utilities, product, processes etc.in line with project, operations and quality objectives. This position is fully onsite Monday-Friday but may have periods of time that require nights or weekends (approx. quarterly) Responsibilities
Work with end-user and project engineer to develop User Requirements Specifications and Functional / Design Specifications for new or modified equipment, facilities, and utilities. Support Factory Acceptance Testing in conjunction with Project Engineer to confirm unit is acceptable. Identify risk controls, critical elements and traceability of equipment design based on FMEA or other risk assessment. Develop and execute commissioning, qualification and validation test protocols to ensure that the unit functions according to specifications. Perform minor troubleshooting of issues encountered during commissioning and documentation of unresolved issues. Able to support broader aspects of projects at times including: project leadership, developing operational procedures, support training of maintenance/technical staff/operators on new equipment, reviewing new or modified product documentation to ensure compatibility with qualified equipment and implementing changes in equipment parameters or recipes. Leads Execution of Risk Management. Qualification as QRM facilitator commensurate with responsibility. May supervise contract validation resources in the timely completion of activities in his/her area of responsibility Qualifications
Bachelor’s Degree in Engineering, science, or closely related discipline is desired, or equivalent technical experience plus demonstrated competence, with a desired 3+ years of significant engineering and/or operational experience. Process and Cleaning Validation Experience Equipment Qualification (IOQ/PQ) Quality System Experience (Veeva, Trackwise, ComplianceWire) Medical Device or Pharmaceutical Experience Required. Statistical Analysis (Minitab or JUMP) Experience in the development of commissioning, qualification, validation and risk management deliverables including specifications and testing protocols that can stand up to regulatory scrutiny. 6+ years of overall experience in Manufacturing, Quality or Engineering including 4 major validation subjects (e.g. Computer, Equipment, Cleaning, Process, etc.) preferred A technical background in medical devices, pharmaceutical, or similar industries (preferred). ISO5 Clean Room Manufacturing experience strongly preferred Strong interpersonal, communication, and negotiation skills with demonstrated ability to work within a team environment. Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing preferred Ability to supervise junior or contract team members (prior supervisory experience preferred) Ability to manage complex projects and multiple projects (5+) simultaneously AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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Validation Engineer III
role at
AbbVie This range is provided by AbbVie. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range
$82,500.00/yr - $157,500.00/yr Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. Job Description An engineering professional that works with project owners, subject designers/engineers and other project team members to plan, and complete tasks associated with commissioning, qualification and validation of new and modified equipment, facilities, utilities, product, processes etc.in line with project, operations and quality objectives. This position is fully onsite Monday-Friday but may have periods of time that require nights or weekends (approx. quarterly) Responsibilities
Work with end-user and project engineer to develop User Requirements Specifications and Functional / Design Specifications for new or modified equipment, facilities, and utilities. Support Factory Acceptance Testing in conjunction with Project Engineer to confirm unit is acceptable. Identify risk controls, critical elements and traceability of equipment design based on FMEA or other risk assessment. Develop and execute commissioning, qualification and validation test protocols to ensure that the unit functions according to specifications. Perform minor troubleshooting of issues encountered during commissioning and documentation of unresolved issues. Able to support broader aspects of projects at times including: project leadership, developing operational procedures, support training of maintenance/technical staff/operators on new equipment, reviewing new or modified product documentation to ensure compatibility with qualified equipment and implementing changes in equipment parameters or recipes. Leads Execution of Risk Management. Qualification as QRM facilitator commensurate with responsibility. May supervise contract validation resources in the timely completion of activities in his/her area of responsibility Qualifications
Bachelor’s Degree in Engineering, science, or closely related discipline is desired, or equivalent technical experience plus demonstrated competence, with a desired 3+ years of significant engineering and/or operational experience. Process and Cleaning Validation Experience Equipment Qualification (IOQ/PQ) Quality System Experience (Veeva, Trackwise, ComplianceWire) Medical Device or Pharmaceutical Experience Required. Statistical Analysis (Minitab or JUMP) Experience in the development of commissioning, qualification, validation and risk management deliverables including specifications and testing protocols that can stand up to regulatory scrutiny. 6+ years of overall experience in Manufacturing, Quality or Engineering including 4 major validation subjects (e.g. Computer, Equipment, Cleaning, Process, etc.) preferred A technical background in medical devices, pharmaceutical, or similar industries (preferred). ISO5 Clean Room Manufacturing experience strongly preferred Strong interpersonal, communication, and negotiation skills with demonstrated ability to work within a team environment. Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing preferred Ability to supervise junior or contract team members (prior supervisory experience preferred) Ability to manage complex projects and multiple projects (5+) simultaneously AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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