Validation Engineer, Mid-Level

Marietta, PA, US • Posted 1 day ago • Updated 6 hours ago
Full Time
On-site
Fitment

Dice Job Match Score™

✨ Finding the perfect fit...

Job Details

Skills

  • Regulatory Compliance
  • Collaboration
  • Quality Assurance
  • Documentation
  • Continuous Improvement
  • Analytical Skill
  • Instrumentation
  • Technical Writing
  • Attention To Detail
  • Communication
  • Life Sciences
  • Pharmaceutics
  • GMP

Summary

Job Description:
We are seeking a highly skilled and experienced Validation Specialist/Engineer to support commissioning and qualification activities for our client's facility in PA. The ideal candidate will have a strong background in executing validation life cycle deliverables in compliance with ISPE C&Q guidelines, with hands-on expertise in analytical instrumentation and controlled temperature unit qualifications.
Responsibilities:
  • Develop, review, and execute validation life cycle deliverables (protocols, reports, and associated documentation).
  • Perform commissioning and qualification activities in alignment with ISPE C&Q guidelines.
  • Support the qualification of analytical instrumentation and controlled temperature units (CTUs).
  • Utilize Kneat e-validation software for document development, execution, and approval (preferred).
  • Ensure compliance with internal quality standards, regulatory requirements, and industry best practices.
  • Provide technical expertise, troubleshooting, and guidance during qualification activities.
  • Collaborate effectively with cross-functional teams, including Quality, Engineering, and Operations.
  • Maintain accurate documentation and contribute to continuous improvement of validation processes.
Qualifications:
  • Minimum 4+ years of experience in commissioning, qualification, and validation within a regulated environment.
  • Strong working knowledge of ISPE C&Q guidelines.
  • Prior experience with analytical instrumentation qualification and controlled temperature unit qualification.
  • Experience with Kneat e-validation software is highly desirable.
  • Excellent technical writing skills with attention to detail and accuracy.
  • Strong verbal and written communication skills.
  • Effective interpersonal skills with the ability to work collaboratively across teams.
  • Bachelor's degree in Engineering, Life Sciences, or related technical discipline.
  • Experience in pharmaceutical or biotech industry.
  • Familiarity with current GMP regulations and validation best practices.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91116760
  • Position Id: e2c2c228d1bd9da756df4d79e34b78f9
  • Posted 1 day ago
Create job alert
Set job alertNever miss an opportunity! Create an alert based on the job you applied for.

Similar Jobs

Pennsylvania

Today

Full-time

Hybrid in King of Prussia, Pennsylvania

23d ago

Easy Apply

Contract

$50 - $59

Marietta, Pennsylvania

Today

Full-time

Pennsylvania

Today

Full-time

Search all similar jobs