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Specialist 2, Validation

2 months ago

Lititz, Pennsylvania, United States Kenvue NA Full time

Kenvue is currently recruiting for:

Specialist 2, Validation
This position reports into Sr Manager MS&T Process Science and is based at Lititz, PA.

Who we are
At Kenvue, we realize the extraordinary power of everyday care.

Built on over a century of heritage and rooted in science, we're the house of iconic brands - including NEUTROGENA, AVEENO, TYLENOL, LISTERINE,JOHNSON'S and BAND-AID that you already know and love.

Science is our passion; care is our talent.

Our global team is made by 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers.

With expertise and empathy, being a Kenvuer means to have the power to impact life of millions of people every day.

We put people first, care fiercely, earn trust with science and solve with courage - and have brilliant opportunities waiting for you Join us in shaping our future-and yours.

For more information, click here.

Role reports to:
Sr Manager MS&T Process Science

Location: Lititz, PA

Travel %: Less than 10%.

What you will do


The Specialist 2, Validation is responsible for creation of validation protocols and reports, investigating validation deviation, identifying discrepancies, developing and executing test plans, preparing and analyzing test results and system validation documentation, and working with customers and quality control group to identify and resolve problems.

As a Specialist 2, Validation, you will proactively identify issues, troubleshoot issues, and escalate concerns as appropriate while adhering to strict procedural and quality standards:

Key Responsibilities

  • Develop and execute validation protocols and reports in accordance with regulatory requirements and industry standards.
  • Collaborate with cross-functional teams to ensure compliance with quality standards and regulations.
  • Perform data analysis and interpretation to support validation activities.
  • Identify and implement process improvements to enhance efficiency and effectiveness of validation activities, escalating concerns as appropriate.
  • Provide technical support and guidance to junior team members.
  • Stay up-to-date with industry trends and regulatory changes to ensure compliance.
  • Contribute to the development and maintenance of quality systems and procedures.
  • Participate in audits and inspections as needed.
  • Conducts thorough investigation and troubleshooting of validation problems for equipment, performance processes, and systems.
  • Analyzes and reviews validation reports for accuracy and correctness, ensuring compliance with test plans, test results, and work procedures.
  • Development of product contact equipment cleaning and sanitization processes
  • Participates in the delivery of system solutions by assuring validation activities are conducted in a cost effective and compliant manner.
  • Develops and executes test plans, performs testing and validation, and prepares and analyzes test results and system validation documentation according to company procedures.
  • Works collaboratively with customers and quality control group to identify and resolve problems.
  • Actively participates in business initiatives that contribute to service excellence.
  • Communicates requirements for validation execution and documentation through daily interactions, training, and other means.
  • Create and execute protocols, reports, and statistical analysis for Continued Process Validation and Annual Drug Product Review process.

What we are looking for

Required Qualifications

  • Bachelor's degree in a scientific or engineering discipline.
  • 2-4 years of experience in validation, testing, or quality control.
  • Strong knowledge of regulatory requirements and industry standards.
  • Excellent analytical and problem-solving skills.
  • Ability to work independently and as part of a team.
  • Strong communication and interpersonal skills.
  • Attention to detail and accuracy.
  • Ability to prioritize and manage multiple tasks and projects.
  • Ability to adhere to strict procedural and quality standards, including thorough and accurate documentation and testing protocols.

Desired Qualifications

  • Experience with statistical analysis software is a plus.
  • Strong analytical and problem-solving skills, with the ability to identify and troubleshoot issues proactively.
  • Excellent communication and interpersonal skills, with the ability to work collaboratively with customers and quality control group.
  • Strong Technical writing skills.
  • Able to support flexible work schedule as required to support validation execution.

What's in it for you

  • Competitive Benefit Package
  • Paid Company Holidays, Paid Vacation, Volunteer Time, & More
  • Learning & Development Opportunities
  • Employee Resource Groups
*Note: Total Rewards at Kenvue include salary, bonus (if applicable) and benefits. Your Talent Access Partner
will be able to share more about our total rewards offerings and the specific salary range for the relevant
location(s) during the recruitment & hiring process.

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment
without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status
and will not be discriminated against on the basis of disability.

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