Validation Specialist, Senior

Validation Specialist/Engineer

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.