What are the responsibilities and job description for the Validation Engineer, Senior position at Katalyst CRO?
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
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.
- 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.