• Job Description

  Req#: 957

  About Phibro Animal Health Corporation

  Phibro Animal Health Corporation is a publicly traded organization with a rich history spanning nearly 100 years of service. The Company is a global manufacturer of medicated feed additives, feed ingredients, advanced nutrition solutions, vaccines and specialty chemicals for various industrial markets. Phibro’s revenues are in excess of $820 million, and are supported by over 1500 employees worldwide.

  The Validation Specialist is an integral part of our Regulatory Affairs team based out of our US - Omaha, NE - Vaccines site.

  Position Details

  The Validation Specialist is an integral part of our Quality team based out of our Phibro Vaccine Omaha Office, in Omaha, NE. The Validation Specialist is responsible for planning, developing, and performing validation and revalidation testing on new and existing equipment and processes. Specific responsibilities include but are not limited to:

  Key Responsibilities

  Create, write, and execute Validation protocols for manufacturing processes and equipment. Identify critical equipment if necessary for new validations. Creation/updating implementation of validation standard operating procedures and working documents. Review and approve site validation and re-validation protocols and reports associated with equipment, facilities, and other engineering activities. Collaborate with Quality Assurance or Production for Production Equipment Validation, Facility Qualification, Cleaning Validation, and Process Validation Activities. Review and approve system change controls associated with equipment and facilities, as well as other select validation activities. Complete and/or approve risk assessments as necessary for validation activities, or as needed for compliance with regulatory requirements. Execution of work is self-directed with collaboration with the Quality team and reporting to the Senior Manager of Quality and Regulatory. Coordinating work activities with relevant stakeholders to maintain required schedules. Other duties as assigned.

  Key Competencies

  Accountable

  Adaptable

  Collaborative

  Committed

  Communicating Effectively

  Critical Thinking

  Customer Service Orientation

  Detailed Oriented

  Driven

  Following Policies and Procedures

  Managing Time

  Prioritizing and Organizing Work

  Problem Solving

  Supporting Organizational Goals

  Using Computers and Technology

  Skills

  A motivated self-starter, work well in groups and demonstrate excellent customer service.

  Ability to work independently.

  Advanced organizational skills.

  Excellent Written and Verbal Communication Skills

  Extremely high level of attention to detail and high standard of quality.

  High degree of time management skills and ability to handle multiple priorities and projects at once.

  Highest ethical standards; ability to be fair and reasonable.

  Education & Experience

  Requires an M S. with three years’ experience. B. S. with five years or equivalent in biological or pharmaceutical industry, or related discipline. A minimum of three years in a Quality role. Experience in validation of processes, analytical methods, equipment, cleaning, software, computer systems, etc. Demonstrated knowledge of the Root Cause/Deviation Investigation, Change Control, Engineering and Manufacturing systems. Knowledge of USDA regulations. Experience in Quality Oversight in a GMP environment helpful. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Must be able to make decisions on routine matters. Ability to define and solve practical problems, collect data, establish facts, and draw valid conclusions. Must function primarily in a worker capacity in a team environment. Have informal contact daily with management. Good organizational and write and execute validation protocols. Work well with others; however capable of extensive independent work. Ability to fluently read, analyze, and interpret the English language in correspondence, general business reports, professional journals, technical procedures, and reports. Ability to apply mathematical formulas to practical situations with laboratory work including conversions and volume measurements of dosages. Also requires computer/software utilization including experience with Word, Excel, PowerPoint, Microsoft Teams, Outlook, and Adobe. Proficient in set-up and use of equipment normally used in calibration and validation. Experience in independently managing multiple tasks and executing all final reports. May need to move boxes; 30lbs to 50lbs. Requires sitting, standing and walking with occasional overtime/weekend work. May include times of extensive standing and sitting. Must be able to stoop, reach, stand, walk, grasp and perform repetitive motions during shift. Requires good eyesight for measurements and hand eye coordination. Office and Lab. Must wear appropriate gowning and Personal Protective Equipment in manufacturing/production areas.

  Physical Requirements

  Required to bend occasionally

  Required to sit frequently

  Required to stand frequently

  Required to talk or hear constantly

  Required to walk frequently

  Phibro is an Equal Opportunity Employer

  All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, gender identity, veteran status, marital status or any other characteristics protected by law.

  Business Unit: Animal Health & Mineral Nutrition
  Division: Animal Health & Nutrition
  Department: Regulatory Affairs
  Location: US - Omaha, NE - Vaccines
  Work Schedule: 1st Shift Weekdays Only
  Weekly Working Hours: 40.00

• About the company

  We are an animal nutrition company dedicated to helping farmers responsibly care for their animals.

Notice