Validation Specialist
4 weeks ago
Immediate need for a talented Validation Specialist. This is a 06+ Months Contract opportunity with long-term potential and is located in Warren, NJ(Onsite). Please review the job description below and contact me ASAP if you are interested.
Job ID: (phone number removed)
Pay Range: $55 - $62/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
Key Responsibilities:
Performs validation document generation, program management, and protocol execution activities.
Interface with Engineering, and end user groups to support development of life cycle documents and system requirements.
Design the validation approach with technical oversight, provide the scientific rationale and acceptance criteria, and generate validation protocols.
Execute validation studies, perform data analysis, and write protocol summaries, reports, and technical reports.
Protocol execution and project activities.
Execute qualification activities with oversight.
Participate in department and site project teams.
Perform qualification activities according to site objectives and timelines.
Edit department SOPs and generate basic revisions as required.
Execute CAPA plans, risk assessments, investigations, and root cause analysis.
Working understanding of site quality GxP systems supporting document management, change controls, deviations, CAPAs.
Defend validation protocols in internal and external audits as a subject matter expert with limited supervision.
Interact and collaborate with departments (on and offsite) as well as vendors, consultants and other external service providers.
Performs general administrative and organizational activities.
Management of time and work deliverables, regular interface and reporting to management.
Complete regulatory, site, and department training requirements on a timely basis.
Key Requirements and Technology Experience:
Bachelor’s degree preferred, preferably in Science or Engineering.
8 years relevant work experience required.
An equivalent combination of education, experience and training may substitute.
Working understanding of validation concepts and requirements.
Intermediate written and verbal communication skills.
Knowledge of cGMP.
Critical reasoning and decision making skills.
Knowledge of validation industry and regulatory requirements.
Ability to work independently and participate in a team.
Work and time management skills.
Working proficiency in Microsoft Word, Outlook, Excel, PowerPoint, and Project.
Our client is a leading Pharmaceutical Industry and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.
Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
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