Validation Engineer

American Laboratories is a great company to work for!

American Laboratories is a growing multi-industry supplier for the extensive products it manufactures. We were founded in 1967 based on the knowledge of manufacturing enzymes, proteins, and flavors to various industries. Today, American Laboratories employs over 125 people, offers an extensive listing of over 300 products to the Human Pharmaceutical, Human Nutritional, Food Processing, and Animal Health industries in the United States and 45 countries around the world.

At American Laboratories, we are looking for candidates with varied backgrounds and skills. Diverse ideas come from diverse people, and we are devoted to offering an all-encompassing work environment where everyone feels valued and respected. Our pace of work enables fast learning and fosters an environment where you can stretch yourself and make an impact. We offer a variety of job specific and business skills programs and trainings to our employees. As a member of our team, you’ll have an opportunity to draw from those resources when you need them, and likewise, contribute your expertise when you have something to share.

We offer a highly competitive compensation package (salary and bonus) as well as a comprehensive, family-friendly benefits package including:

• Exceptional family medical, dental, and vision benefits (100% company paid premiums). 100% paid deductible/out of pocket expenses for Medical
• Paid time off and sick leave
• 9 paid holidays
• Exceptional 401k fund contributions (up to 9%)
• Great schedules
• Wellness incentives

Pay is based on experience.

Take your career to the next level by applying today!

Validation Engineer

We have a career opportunity for a Validation Engineer.  You will be responsible for supporting the function and responsibilities of American Laboratories, LLC’s (ALI) Technical Services/Product Research and Development department in collaboration with other organizational departments.

The Validation Engineer will be located at 5036 S 33rd St. in Omaha, working with different management levels and support personnel in other office locations.

The impact you will have:

• Will support the troubleshooting of operations and processing issues by performing lab-scale processing and/or data analysis review.
• Will support developing new and optimizing current product for both internal and external production.
• Will lead the development, implementation and closure of Change Controls, Deviation investigations and Corrective Actions/Preventative Actions (CAPA) within a timely manner.
• Will generate and execute Installation/Operational/Process Qualification/Process Validation (IQ, OQ, PQ, PV) protocols and related summary reports.
• Will support the Validation Master Plan and Calibration program activities in accordance with current USDA and FDA cGMPs.
• Will collaborate with others to identify areas of improvements and facilitate the revision and approval of Standard Operation Procedures (SOP), Manufacturing Instructions (MI) and other documents.
• Will perform risk assessments and support implementation of identified improvements.

What we are looking for:

• Bachelor’s degree in a Science related field with a minimum of 6 years’ experience in an USDA and/or FDA regulated industry, preferred.
• (Preferred) Masters and/or PhD degree in sciences.
• A minimum of 3 years of qualification/validation experience.
• Knowledge of US FDA 21 CFR Part 117 and Q7 cGMP requirements.
• Self-motivated with a results driven approach and have the ability to manage multiple projects/tasks simultaneously.
• Strong written and verbal communication skills, including the ability to organize information and present it to peers and members of Senior Management.
• Proficiency in Windows applications (Word, Excel, PowerPoint, Outlook, etc.) and other basic computer skills.

American Laboratories is an Equal Opportunity Employer and participates in E-Verify.