Cleaning Validation & Commissioning Specialist

About AbbVie 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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description An engineering professional who 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, products, 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. Responsibilities Develop and execute commissioning, qualification and validation test protocols. Able to support broader aspects of projects at times, including project leadership, developing operational procedures, supporting training of staff/operators on new equipment or processes, reviewing new or modified product documentation to ensure compatibility with qualified equipment/processes, and implementing changes as necessary. Lead the execution of risk management, including periodic review and update per the Validation Master Plan, interface with best practices, establishing team and work practices, including overall program and ccRA. Understand risk management principles, find and review documentation, understand controls, impact of change, trace controls, and estimate ratings using appropriate scale. Demonstrated success in FMEA authorization/facilitation. May supervise contract validation resources in the timely completion of activities in his/her area of responsibility. Coordinate and execute sampling related to cleaning validation following established procedures and applicable protocols. Document results obtained and completion of cleaning validation summary reports accurately as required. Generate and process change requests per the applicable procedures. Lead the implementation of special projects related to the cleaning validation area. Prepare area reports and presentations as applicable. Provide assistance to operations in accordance with environmental management, occupational health and safety (EH&S) systems, promote continuous improvement, comply with all EHS procedures and policies including incident reporting, use of PPE, waste management and disposal, and any other applicable program according to position duties. 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. 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 health care, nutritional products, laboratory diagnostics, medical devices, pharmaceutical, or similar industries 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. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that can be allocated to a particular employee remains in the Company’s sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. 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. US & Puerto Rico only – to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: #J-18808-Ljbffr AbbVie