CSV Engineer

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 CSV Engineer is an integral part of our Operational Systems team based out of our US - Teaneck, NJ - Remote site.

Position Details

The CSV Engineer has a primary focus to partner with the Business and System Owners, Quality, and the Global IT Computer Systems Validation (CSV) Director to define and execute Phibro ERP and Manufacturing System's Validation with strong risk-based approach, support internal and external audits, and identify opportunities to improve Catalent's CSV methodology.

This role will be responsible for quality oversight of validation/qualification efforts supporting computerized systems (including equipment/instruments with a computer component) ensuring compliance to quality objectives and regulatory requirements. In addition, working on problems that are complex in scope where analysis of situations or data requires in-depth evaluation of various factors. Exercising sound judgement within defined practices and policies in selecting methods, techniques and evaluation criteria for resolving problems and obtaining results is essential.

This position reports to the CSV Manager and Operations and will work closely with the other members of the organization to meet the program's goals.

Key Responsibilities

• Manages all CSV Engineering functions- including organizing and prioritizing daily tasks, performing training, and writing performance reviews.

• Provides IT CSV oversight for GXP computerized systems and applies risk-based methodology to validation/qualification efforts in compliance with 21 CFR Part 11, EU Annex 11, and GAMP.

• Provides IT CSV oversight of deviations, CAPAs, and change controls related to GXP computerized systems.

• Reviews and creates validation documentation - such as user requirements functional requirements, validation plans, IQ/OQ/PQ documentation, risk assessments and VSR's.

• Analyzes, develops, tests, and deploys configuration, workflow, and/or reporting to improve the overall accuracy, efficiency, and effectiveness of the electronic computerized system.

• Effectively identifies and resolves system issues and appropriately communicates gating items to senior management and stakeholders.

• Reviews and audits CSV for IT systems according to 21 CFR Part 11, Annex 11, and other regulatory requirements.

• Participates in the development and improvement Quality Assurance programs, policies, processes, procedures and controls ensuring compliance with current Good Manufacturing Practices (cGMP) expectations and established agency requirements/guidelines.

• Supports the external audit program for vendors related to GXP computerized systems.

• Participates in cross-functional project teams.

• May support and interface with regulatory agencies as required in support of regulatory agency inspections.

Key Competencies

Accountable

Adaptable

Attentive Listening

Championing Customer Needs

Collaborative

Committed

Communicating Effectively

Creating and Maintaining Networks

Customer Service Orientation

Delivering High Quality Work

Critical Thinking

Demonstrating Initiative

Detailed Oriented

Displaying Technical Expertise

Following Policies and Procedures

Initiative and Responsibility

Interacting with People at Different Levels

Interpersonal Skills / Communication

Managing Time

Prioritizing and Organizing Work

Problem Solving

Showing Caring and Understanding

Supporting Change

Supporting Coworkers

Supporting Organizational Goals

Testing and Troubleshooting

Thinking Globally

Using Computers and Technology

Working with Diverse Populations

Skills

Advanced skills using Microsoft office programs.

Must be proficient using Email, phones, cell phones, and office equipment.

Proficient with Adobe Professional and Microsoft Office Products.

Proven ability to work effectively in a team environment.

Excellent Written and Verbal Communication Skills

Interpersonal skills sufficient to communicate verbally and in writing with others in an objective and cooperative manner.

Ability to maintain a positive attitude and treat each client and coworker with courtesy and respect.

Ability to translate client needs into products/services.

Ability to work with multiple departments and a varying portfolio of clients

Able to handle client complaints with calm demeanor and professional attitude.

Able to technically assist and understand client needs and provide problem resolution.

Develop and maintain relationships with internal and external clients.

Must have business acumen, energy and drive, positive attitude, client focused, flexible and empathetic.

Must have planning skills sufficient for establishing work priorities and meeting client commitments.

Education & Experience

• Bachelor's degree or equivalent experience in Software Engineering or another related field.

• Substantial experience in CSV of GCP/GLP/GCLP/PVQA eSystems.

• Prior experience in leading or managing CSV projects.

• Experience supporting regulatory inspections.

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: Corporate

Division: Corporate

Department: Operational Systems

Location: US - Teaneck, NJ - Remote

Work Schedule: Monday - Friday (Standard Work hours)

Weekly Working Hours: 40.00