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Computer System Validation Specialist

Company: Xybion Corporation
Location: Princeton
Posted on: January 16, 2022

Job Description:

About Us

Xybion is a leading software, services, and consulting company dedicated to helping corporations solve business problems. Through intelligently designed systems and business processes, we help companies become more efficient, reduce costs and manage compliance, regulatory adherence and risk. Serving more than 150 customers in 16 countries. Xybion has the global scale and expertise to bring employees around the world together to manage complex business processes and improve program administration.

Our unique solutions focus on integrated preclinical lab management, early-stage drug discovery, employee health & safety, quality management, regulatory compliance, GLP, content migration and systems validation. Since its founding in 1977, Xybion Corporation has supported, through software, services and consulting, 100% of the top 20 global life sciences companies.

Computer System Validation (CSV) Specialist

We are growing rapidly, and currently searching for a number of technical resources, including a CSV Specialist.

In this role you'll lead and implement validation and compliance projects for our pharma and biotech clients, developing validation documentation for systems used in GLP, GMP and GCP environments.

Location:

You can work remotely, collaborating with colleagues at our New Jersey headquarters and elsewhere.

Key Responsibilities:
Gather user / business requirements and define the overall Validation / Test approach and plan based on those requirements
Apply FDA, cGMP and other applicable regulatory requirements to the validation of the system, hardware and software supporting the business process
Facilitate the Computer System Validation Risk Assessment to identify governing regulations and validation deliverables during the development of the project
Lead/ Co-ordinate with the internal Validation team to ensure all CSV deliverables are created, executed and reviewed on time and with good quality. The CSV deliverables include Validation Plan, IQ, OQ and PQ protocols, test scripts, risk assessments, reports, traceability matrices, and validation summary reports
Maintain close communication with customer stakeholders and internal team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues
Work with technical teams to perform trouble-shooting activities during the validation process

Essential Qualifications:
10-12 years of experience in the Pharmaceutical, Medical Device or other Biotech Manufacturing Industry.
Bachelor's degree in a scientific, regulatory, or technical discipline; or Associates degree with 12+ years' relevant experience in regulated industry
Knowledge of the Software Development Life Cycle, Change Control Management testing and implementation of business applications.
Deep experience generating and reviewing Computer Systems Validations CSV Deliverables according to 21 CFR Part 11 and FDA regulations for the pharmaceutical industries
Working knowledge of GLP, GCP, GMP, GAMP V guidelines especially in the areas of computer or related systems
Experience with issue-tracking, defect-management and/or version control systems.
Proficient working in Microsoft Office applications
Experience with Agile methodology.
Skilled in project management.
Prior experience supervising teams of personnel helpful.
A natural problem-solver; driven; quick to learn.
Positive, collaborative and constructive a true team player.

Compensation:

We offer highly competitive compensation, including a performance-linked bonus, along with a comprehensive benefits package.

We thank all applicants for their interest; however, only those selected for an interview will be contacted. For more information about Xybion, please visit https://www.xybion.com/.

Xybion is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

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Keywords: Xybion Corporation, Trenton , Computer System Validation Specialist, IT / Software / Systems , Princeton, New Jersey

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