Becton, Dickinson and Company

Quality Engineer II (Validation)

Becton, Dickinson and Company • $75K — $121K *
Hunt Valley, MD 21031In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in Biological Sciences, Chemistry, or related science field.
  • 2 years experience in Quality, Scientific Operations, or Engineering.
  • Preferred technical writing experience in validations.
  • Experience in a medical device or pharmaceutical manufacturing setting.
  • Familiarity with FDA regulations and ISO standards.

Responsibilities

  • Develop and maintain Quality System procedures, SOPs, and policies.
  • Lead and execute validation activities for manufacturing plants.
  • Monitor and analyze quality indicators for materials and products.
  • Conduct risk assessments to support product quality and process predictability.
  • Initiate and manage Corrective and Preventive Actions (CAPAs).
  • Support continuous improvement initiatives to enhance quality and efficiency.
  • Collaborate with cross-functional teams to support launches and quality initiatives.

Benefits

  • On-site collaboration to foster innovation and effective problem-solving.
  • Minimum of 4 days in-office presence for most roles, with flexibility options.
  • Supportive culture that emphasizes work-life balance.
Full Job Description
Job Description

The Quality Engineer II, Validation is responsible for supporting and maintaining Quality Systems across Media manufacturing plants, with a primary focus on validation writing, execution, and compliance. This role ensures consistent application of quality standards, drives continuous improvement initiatives, and partners cross-functionally to support manufacturing operations, product quality, and regulatory compliance.

Responsibilities
  • Develop, implement, and maintain Quality System procedures, Standard Operating Procedures (SOPs), and quality policies.
  • Lead and execute validation activities, including change validations and recurring process/equipment qualifications for Media plants and IDAST.
  • Monitor, trend, and analyze quality indicators for purchased materials, manufactured products, and distributed components.
  • Assess Critical to Quality (CTQ) parameters and perform risk assessments to support product quality, process predictability, and decision-making.
  • Apply statistical tools and data analysis techniques to identify root causes, resolve quality issues, and implement effective corrective actions.
  • Initiate and support Corrective and Preventive Actions (CAPAs), including leading investigations and corrective action activities when required.
  • Support process control initiatives and promote consistent manufacturing practices across operations.
  • Identify and recommend continuous improvement opportunities to enhance product quality, operational efficiency, and compliance.
  • Manage day-to-day Quality Management (QM) Engineering activities for assigned products and operational projects.
  • Partner with manufacturing, engineering, and cross-functional teams to support product launches, process improvements, and quality initiatives.
  • Ensure consistent implementation and application of Quality Systems for both new and existing product lines.
  • Maintain compliance with FDA regulations, ISO standards, and other applicable quality and regulatory requirements.
  • Support quality-related activities including change controls, product quality notifications, post-market activities, IVDR compliance, and customer complaint investigations.
  • Utilize enterprise systems and quality tools to drive compliance, documentation accuracy, and process efficiency.
  • Serve as a subject matter expert (SME) during internal and external audits, as needed.
  • Foster collaborative and inclusive working relationships across departments that support Media manufacturing operations


REQUIRED QUALIFICATIONS
  • Bachelor's degree in Biological Sciences, Chemistry, or other related science field.
  • 2 years experience in Quality, Scientific Operations, or Engineering.


PREFERRED QUALIFICATIONS
  • Experience in technical writing and managing process and test method validations.
  • Experience in a medical device or pharmaceutical manufacturing facility.


SKILLS AND KNOWLEDGE
  • Basic knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization ISO 13485 and 14971.
  • Ability and management plans skill to effectively manage multiple tasks and drive execution of change
  • Ability and skill to lead or manage process control, supplier quality, and continuous improvement projects using statistical technique/tools such as: Statistical sampling, SPC, Six sigma, additionally root cause analysis and project management techniques are routinely employed.
  • Ability to effectively write communications that ensures clarity, accuracy, and consideration of the audience.
  • Ability to speak with clarity and express points of view in a variety of settings; one-on-one interactions, group meetings, and formal presentations.
  • Ability to listen to others; including associates, managers, peers and customers when making decisions and solving problems.
  • Ability and skill to analyze data using systematic analytical tools such as Six Sigma, root cause analysis, failure analysis and risk assessment to gather critical information that has moderate to difficult complexity.
  • Knowledge of automated systems for filling and packaging are a plus.


At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

Primary Work Location
USA MD - Hunt Valley

Salary Range Information
$75,800.00 - $121,300.00 USD Annual

About Becton, Dickinson and Company

BD is a global technology company that provides diagnostics and technologies for frontliners. Through their solutions and services, they assist scientists in detecting diseases and advanced researchers' on developing diagnoses and therapeutics. BD was established in 1897 by Farleigh Dickinson and Maxwell Becton in East Rutherford, New Jersey.

Becton, Dickinson and Company Careers

Join the innovative world of Becton, Dickinson and Company (BD), a global medical technology company that is actively seeking driven, dedicated professionals to join our team. At BD, we are committed to advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. This commitment provides the foundation for a workplace where you can engage in meaningful work and where job opportunities abound.

Work You’ll Do

At BD, you will be part of a culture that values diversity, leadership, and innovation. Our team members are empowered to lead and inspire from day one. Join us and contribute to our mission of advancing the world of health through your professional skills and personal passion.

Transform Your Career

BD offers a unique position in the marketplace that combines industry expertise, leadership in medical innovation, and a collaborative culture to help you grow your career. Whether you are looking for an entry-level position or a more senior role, we provide the tools and support for your professional growth through comprehensive training and development programs.

Innovative Work Environment

Our team at BD is composed of more than 65,000 associates across the globe. These dedicated professionals work at the intersection of technology and healthcare, where they drive innovation and ensure that we stay ahead in a rapidly evolving industry. By joining BD, you will work alongside some of the brightest minds in the industry.

Internship and Employment Opportunities

Start your career with BD through our internship programs or dive straight into a full-time position. We offer a range of opportunities that allow you to explore different areas of our business and find a path that aligns with your career goals. Our hiring process is designed to be transparent and engaging, ensuring that all candidates—whether submitting a resume for an internship or a senior position—feel valued and informed.

Benefits and Culture

BD is proud to offer competitive benefits that support the health, well-being, and financial security of our employees and their families. From comprehensive health insurance to employee wellness programs and flexible working arrangements, we prioritize the well-being of our team members. Our inclusive culture encourages networking, continuous learning, and the sharing of ideas in a diverse and welcoming environment.

Join Our Team

Explore the job opportunities at BD and discover how your expertise can help shape the future of healthcare. Search open positions that match your skills and interests. We look for passionate, curious, creative, and solution-driven team players.

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Explore Careers at BD

Whether you're preparing for your first interview or looking to advance into a leadership role, BD offers career paths that foster continuous growth and innovation. Join us in our mission to improve medical outcomes and enhance patient care worldwide.

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At Becton, Dickinson and Company, we are more than just a company; we are a community that is dedicated to making a difference in the lives of people all around the world.
Learn more about Becton, Dickinson and Company
Size
75,000 employees
Market Cap
$72 billion
Industry
Healthcare
Net Income
$1.6 billion
Founded
1897
5 Year Trend
+9.3%
Revenue
$18.2 billion
NASDAQ
BDX
* Ladders Estimates

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