Validation Engineer III

Engineering Professional

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. Level of responsibility and performance is commensurate with grade level. The main objective is to establish evaluation, testing and documentation for risk management, commissioning and validation applying product and regulatory requirements and risk management to result in robust, high quality products. This includes optimizing systems that support the work in and around this area of responsibility.

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. including, periodic review and update per the Validation Master Plan, interface with best practices, establishing team's work practices including overall program, ccRA. Understands risk management principles. Can find and review documentation. Understands controls, impact of change, trace controls, and can estimate ratings using appropriate scale. Timely. Demonstrated success in FMEA authorization/facilitation.
• 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. Preferred Medical Device with 3-5 Years
• 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

Additional Information:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.
• This job is eligible to participate in our long-term incentive programs

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.