Validation Specialist, Senior

Karwell Technologies

Marietta, PA

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JOB DETAILS

SKILLS

Best Practices, Biology, Biotech and Pharmaceutical, Commissioning, Commissioning - Engineering, Communication Skills, Continuous Improvement, Cross-Functional, Detail Oriented, Documentation, GMP (Good Manufacturing Practices), Identify Issues, Instrumentation, Interpersonal Skills, Maintain Compliance, Presentation/Verbal Skills, Process Improvement, Quality Engineering, Quality Metrics, Regulations, Regulatory Requirements, Software Development, Team Player, Technical Writing, Validation Documentation, Writing Skills

LOCATION

Marietta, PA

POSTED

30+ days ago

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.

About the Company

Karwell Technologies

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