Validation Engineer

Job Title: Validation Engineer
Location: Mt. Prospect, IL
Duration: 9-12+months

Job Description:
we are seeking a highly skilled Validation Engineer to coordinate and execute cleaning validation activities in our pharmaceutical manufacturing environment. The ideal candidate will have strong expertise in developing and validating cleaning procedures, conducting investigations, and ensuring compliance with regulatory standards.


Key Responsibilities:

• Develop and coordinate cleaning validation activities, including protocol preparation and execution.
• Investigate deviations and discrepancies related to cleaning validation processes.
• Oversee and review validation processes to ensure regulatory compliance.
• Design and develop cleaning procedures for new products and manufacturing equipment.
• Provide technical support and troubleshooting for cleaning processes.
• Establish and implement sound cleaning practices within manufacturing and sampling suite areas.
• Lead the development of cleaning strategies for product transfers and new product development.
• Conduct root cause analysis of cleaning-related incidents and deviations.
• Enhance cleaning practices, including the introduction of "clean in place" (CIP) equipment.
• Review and approve manufacturing cleaning working instructions and forms.
• Support periodic reviews of cleaning validation studies and related documentation.
• Manage change controls for the implementation of new or updated cleaning procedures.
• Train manufacturing and quality personnel on cleaning validation documentation.

Qualifications:

• Bachelor's or master's degree in science, Pharmacy, or Engineering.
• Minimum of 5 years of experience in cleaning validation within pharmaceutical or biotechnology industries.
• Strong knowledge of cleaning validation, process improvement, and troubleshooting techniques.
• Demonstrated project management and organizational skills.
• Ability to work independently and collaborate effectively in a team environment.
• Strong problem-solving, analytical, and risk assessment skills.
• Excellent technical writing, presentation, and communication skills.
• Proficiency in cGMP, OSHA, and FDA regulations relevant to the pharmaceutical industry.

Additional Information:
Only local candidates who can attend onsite interviews will be considered.