Cleaning Validation & Commissioning Specialist

Regulatory Jobs; North Chicago (IL); Presencial; USD 90 000 - 150 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Paid time off

Medical/dental/vision insurance

401(k)

Short-term incentive programs

Resumo da oferta

AbbVie is seeking an engineering professional to plan and complete commissioning, qualification and validation activities for equipment, facilities and processes. The role emphasizes risk management, documentation, and ensuring regulatory compliance to deliver robust, high-quality products.

You'll lead validation efforts, collaborate across project teams, and coordinate contract resources while supporting environmental, health and safety programs.

Qualificações

• Bachelor's Degree in Engineering or related field with 3+ years of engineering/operational experience.
• Experience developing commissioning, qualification, validation and risk management deliverables for regulatory scrutiny.
• 6+ years in Manufacturing, Quality or Engineering with 4 major validation subjects preferred.
• Technical background in healthcare/pharmaceutical or related industries preferred.
• Strong interpersonal, communication and negotiation skills; team-oriented.
• Knowledge of quality/compliance management and API/Bulk Drug/Finished goods regulations.
• Ability to supervise junior or contract team members.
• Ability to manage complex projects and multiple projects (5+) simultaneously.

Responsabilidades

• Develop and execute commissioning, qualification and validation test protocols.
• Support broader project aspects including leadership, operational procedures, staff training on new equipment or processes.
• Lead risk management execution and maintain validation master plan alignment.
• Review documentation, assess controls, change impact, and estimate ratings; facilitate FMEA.
• Supervise contract validation resources as needed.
• Coordinate sampling for cleaning validation and prepare related reports.
• Generate and process change requests; lead related projects.
• Prepare area reports and presentations; support EH&S compliance.

Conhecimentos

Validation

Risk management

Project leadership

Quality compliance

Supervisory

Cross-functional

Formação académica

Bachelor's degree in Engineering

Descrição da oferta de emprego

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, visit www.abbvie.com.

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. 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, support training of staff/operators on new equipment or processes, reviewing new or modified product documentation to ensure compatibility with qualified equipment/process and implementing changes as necessary.
• Leads execution of Risk Management, including periodic review and update per the Validation Master Plan, interface with best practices, establishing team & 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.
• May supervise contract validation resources in the timely completion of activities in his/her area of responsibility.
• Responsible for the coordination and the execution of the sampling related to cleaning validation following the established procedures and applicable protocols. Document the results obtained and complete cleaning validation summary reports accurately as required.
• Generate and process change requests per the applicable procedures.
• Lead the implementation of special projects related to 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 and promote continuous improvement. Comply with all EHS procedures and policies including incident reporting, use of PPE, waste management and disposal, and any other program applicable according to the 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.

Compensation & Benefits

• The compensation range 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. Individual compensation will depend on many factors including geographic location.
• 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.

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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation: https://www.abbvie.com/join-us/reasonable-accommodations.html