39 applicants
Phibro Animal Health · 3 days ago
CSV Engineer
Teaneck, NJ
Full-time
Onsite
Entry, Mid Level
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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.
Qualification
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Required
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.
Advanced skills using Microsoft office programs.
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.
Company
Phibro Animal Health
Phibro Animal Health Corporation is dedicated to helping meet the growing demand for animal protein.
Founded in 2000
1,001-5,000 employees
Funding
Current Stage
Public CompanyTotal Funding
$550M2021-04-22Post Ipo Debt· $550M
2014-04-11IPO· nasdaq:PAHC
2008-03-01Acquired· by 3i Group
Leadership Team
Glenn David
CFO
Richard Johnson
interim Chief Financial Officer
Recent News
2024-05-20
2024-05-20
2024-05-20
Company data provided by crunchbase
