Manager of Validation

Company: American Laboratories
Location: Omaha
Posted on: March 19, 2023

Job Description:

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), paid time off, 401k with company match, employee short-term and long-term disability, basic life insurance (100% company paid premiums), great schedules, wellness incentives, and all-around great people to work with. Take your career to the next level by applying today! Manager of Validation We have a career opportunity for a Manager of Validation. As a Manager of Validation, you will be responsible for ALI Pharmaceutical Manufacturing, LLC's (ALI-PM) validation program activities, including managing resources, projects, investigations and objectives. The manager will be located at 4410 S 102nd St. in Omaha, working with different management levels and support personnel in other office locations. The impact you will have:

• You will manage and support validation and investigation activities, including management of Technical Services employees.
• You will oversee, manage and support pocess qualification, process validationa dn cleaning validation protocols and develp summary reports, inlcuding correspondign periodic reviews.
• You will support pocess development activities in collaboration with other departments and other project teams.
• You will write technical protocols and reports and present results to diverse audiences of internal and external stakeholders.
• You will generate, update and approve standard operating procedures (SOPs).
• You will manage and support change control, deviation and corrective and preventative actions development, out-of-speciifcation and out-of-trend laboratory investigations, approval and implementations.
• You will create and maintain user and process requirements and risk assessments.
• You will oversee the validation master plan list and coordinate completion of the activities.
• You will support equipment qualifications and calibration activities, as necessary.
• You will participate in and report Engineering deparment performance outputs wit bracketing and trending during mangement reviews and Current Good Manufacturing Practices (cGMP) meetings. What we are looking for:
  • You will have a Bachelor's degree in Engineering or related field. Master's degree in Engineering or related field preferred.
  • You will have a minimum of 5 years of experience with validation, qualification and engineering with U.S. Food and Drug Administration (FDA) and cGMP environments required.
  • You will have experience managing quality systems documentation and performing root cause analysis and investigations.
  • You will have experience managing people, includingconflict resolution, team building and development.
  • You will have strong written and verbal communication skills.
  • You will be proficient in Windows applications (Word, Excel, PowerPoint, Outlook, etc.) and other basic computer skills.

Keywords: American Laboratories, Omaha , Manager of Validation, Executive , Omaha, Nebraska