Phibro Animal Health Corporation A Teaneck , NJ 07666
Posted 2 months ago
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
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