Job Description

Validation Area Specialist I - Contract - Clayton - NC

We are on the hunt for bold, innovative thinkers who are ready to help push the boundaries of science and make a tangible difference in the world.

Proclinical is seeking a Validation Area Specialist I to join our client's team in Clayton, NC.

Primary Responsibilities:

The successful candidate will focus on performing revalidation of equipment and processes, supporting validation activities for both existing and new systems. Your work will be crucial in areas such as formulation, sterilization, cleaning, filling, and inspection.

Skills & Requirements:

• Bachelor's degree in engineering, Computer Science, or a related field.
• Experience in validation within the pharmaceutical or medical device industry.
• Familiarity with quality concepts and compliance review of validation documents.
• Knowledge in core validation areas such as sterilization and cleaning.
• Understanding of cGMP documentation practices and regulations.
• Proficiency in Microsoft Word and Excel.
• Strong communication skills.
• Experience with validation test equipment like temperature mapping tools.
• Ability to collaborate effectively in project teams.
• Problem-solving skills using root-cause analysis techniques.
• Organizational and planning skills for managing complex projects.

The Validation Area Specialist I's responsibilities will be:

• Conduct and review revalidation activities, coordinating with various departments.
• Author and review documents to ensure compliance with local, corporate, and regulatory standards.
• Collaborate on IQ, OQ, and PQ protocols within set timeframes.
• Lead or support investigations using root cause analysis to resolve issues and prevent recurrence.
• Engage in continuous improvement initiatives using cLEAN tools.
• Ensure accuracy and compliance of executed protocol data.
• Manage Change Requests related to revalidation and other validation activities.
• Prepare and review validation procedures, specifications, and quality documents.
• Present and support validation concepts during audits and inspections.
• Adhere to safety and environmental requirements.
• Align with company values, demonstrating a Quality and cLEAN® Mindset.
• Perform additional duties as assigned.

If you are having difficulty in applying or if you have any questions, please contact Anderson Maldonado at [email protected]

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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