Job Title: Validation Process Engineer

Job Description

We are seeking a dedicated Validation Process Engineer to join our team in a dynamic chemical manufacturing environment. You will play a critical role in validating manufacturing processes, particularly focusing on 190 proof Ethanol, and ensuring compliance with FDA regulations. This position offers a unique opportunity to work on diverse product lines and contribute significantly to our growth and innovation efforts.

Responsibilities

• Validate the manufacturing process for 190 proof Ethanol and the subsequent final drug product.
• Develop and execute validation protocols and ensure compliance with FDA regulations.
• Conduct validation testing and adjust equipment with precision to meet established standards.
• Collaborate cross-functionally with chemical compounders, operators, and the lab to ensure seamless implementation of validated processes.
• Prepare and oversee the production of three batches of the product as part of the validation process.
• Implement corrective and preventative actions based on audit findings.
• Draft validation documentation and ensure accurate record-keeping to pass customer audits.

Essential Skills

• 3+ years of experience in process validation, ideally in the food, chemical, or pharmaceutical industries.
• Proven experience with FDA regulations and validation of consumer goods/manufacturing processes.
• Strong communication skills to effectively collaborate with cross-functional teams.
• Experience with validation testing and equipment validation.
• Ability to work independently and guide the direction of process flow to the end product.

Additional Skills & Qualifications

• Chemical engineering knowledge is advantageous.
• Experience with hazardous chemicals is beneficial.
• A Bachelor's Degree is not required; relevant experience is highly valued.

Work Environment

The role is based in a chemical manufacturing environment, with time spent both on the production floor and in an office cubicle setting. The position involves hands-on work with various equipment and requires adherence to safety protocols.