AbbVie

Cleaning Validation & Commissioning Specialist

AbbVie • $90K — $120K *
North Chicago, IL 60064In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's Degree in Engineering, science, or related discipline, or equivalent experience with 3+ years in relevant fields
  • Experience developing commissioning and validation documents compliant with regulatory standards
  • 6+ years in Manufacturing, Quality or Engineering, including expertise in at least 4 validation areas
  • Technical background in healthcare, nutritional products, or pharmaceuticals preferred
  • Strong interpersonal and communication skills for effective teamwork
  • Knowledge of compliance regulations affecting pharmaceutical manufacturing
  • Supervisory experience managing junior or contract team members

Responsibilities

  • Develop and execute test protocols for commissioning, qualification, and validation
  • Support project leadership and training on new equipment or processes
  • Lead risk management execution and interface with best practices
  • Review documentation to ensure compatibility with qualified processes
  • Supervise contract validation resources for timely task completion
  • Coordinate and execute cleaning validation sampling and document results
  • Generate change requests per established procedures
  • Prepare reports and presentations for area-related projects
  • Assist operations in compliance with environmental health and safety systems

Benefits

  • Comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k)
  • Opportunity to participate in short-term incentive programs
Full Job Description
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 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 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


Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
  • 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 are allocable 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.

About AbbVie

AbbVie develops pharmaceuticals and medical devices. They provide products and services to therapeutic areas including immunology, oncology, neuroscience, eye care, virology, women's health, and gastroenterology.

AbbVie Careers

Joining AbbVie means becoming part of a global team dedicated to making a remarkable impact on patients' lives. At AbbVie, our employees are united in the pursuit of groundbreaking innovation and are committed to transforming the future of healthcare with leading-edge science.

Work You’ll Do

At AbbVie, you’ll collaborate with some of the brightest minds in the industry to solve challenging problems that have a high impact on society. Our culture fosters growth and embraces leadership and diversity training, ensuring that every team member can thrive.

Explore Job Opportunities

AbbVie offers a wide range of job opportunities and career paths, providing a platform where professionals can propel their careers forward. From research and development to marketing and sales, the potential to make a significant impact is limitless.

Internship Programs

Kickstart your career with an AbbVie internship. Our programs provide invaluable industry experience and a chance to develop essential skills in a real-world setting. Interns at AbbVie are considered integral members of the team and are given tasks that are both challenging and rewarding.

Professional Growth and Development

We believe in nurturing our team's professional growth through comprehensive training programs, leadership development opportunities, and continuous learning. Our commitment to your career growth is reflected in our robust offerings that enhance your skills and knowledge.

Benefits and Culture

AbbVie is dedicated to supporting our employees' well-being both inside and outside of work. Our benefits package includes health, financial, and social benefits that are designed to support the diverse needs of our employees. Our inclusive culture encourages collaboration and innovation, fostering a workplace where all can excel.

Hiring Process

Our hiring process is designed to ensure a match that will be beneficial both for the company and for your career aspirations. From resume submission to interview, each step is an opportunity to showcase your skills and fit with the AbbVie team.

Networking and Career Advancement

At AbbVie, networking doesn’t just enhance your career; it propels it. We encourage our employees to engage internally and externally to build relationships that foster personal and professional growth.

Join Our Team

Search open positions that match your skills and interests. We are looking for passionate, curious, and innovative team players who are ready to make a difference.

Stay Connected

Keep up to date with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here.

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Personalize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding opportunities that await at AbbVie.

Explore AbbVie Jobs

Whether you’re seeking to advance your career in a dynamic and empowering environment, or looking for a place where you can innovate, lead, and contribute to something bigger, AbbVie is the place for you. Join us in our mission to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow.
Learn more about AbbVie
Size
50,000 employees
Market Cap
$288.5 billion
Industry
Pharmaceuticals & Biotech
Net Income
$4.6 billion
Founded
2013
5 Year Trend
+17%
Revenue
$45.8 billion
NASDAQ
ABBV
* Ladders Estimates

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