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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 and create SOPs, if necessary, for new validations
  • Review and approve site validation and re-validation protocols and reports associated with equipment, facilities, and other engineering activities
  • Collaborate with QA 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, B. S. with five years or equivalent in biological or pharmaceutical industry, or related discipline. A minimum of three years' experience with engineering validation activities. 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 Deviation Investigation, Change Control, Engineering and Manufacturing systems. Knowledge of USDA regulations. Experience in Quality Oversight in a GMP environment helpful. 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. 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. 

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 

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