Title: Lab System Admin/ GXP Validation Engineer
Location: Rahway, NJ
Pay Rate: $58/hr on C2C
Mandatory Skills: IT Controls methodologies, including GAMP5 and ITIL
Job Description:
- Resource will provide dedicated support for various laboratory systems within our state-of-the-art pharmaceutical facility.
- Responsibilities include but are not limited to:
- Provide software support for various laboratory systems such as Maldi-TOF, Coulometer, qPCR etc.. in Pharmaceutical Operations
- Support the Pharm Ops Quality Control Operations department in preventing unplanned downtime of their systems.
- Adhere to the requirements of “Segregation-of-Duties” in the management of the systems in scope.
- Demonstrated leadership skills with a proven track record of driving continuous improvement
- Excellent communication and interpersonal skills with the ability to influence others with impact
- Advanced knowledge of system vulnerabilities and security issues.
- Monitor the system daily and respond immediately to security or usability concerns.
- Create and verify backups of data
- Respond to and resolve help desk requests
- Upgrade systems and processes as required for enhanced functionality and security issue resolution
- Manage the configuration and operation of client-based computer operating systems
Qualifications:
Education Requirement:
Bachelor’s Degree in Computer Science, Management Information Systems or equivalent degree.
At least 2 years of experience working in a similar position in Bio-Technology, or Life Science industry
Required Experience and Skills:
MUST have thorough understanding of IT Controls methodologies, including GAMP5 and ITIL.
Thorough knowledge of computer validation/SDLC requirements and change control procedures ?
Effective verbal or spoken communication skills
Good communication skills in English
Preferred Experience and Skills:
At least 3 years of experience working in a similar position within a GxP regulated environment
Sufficient experience in GxP validated, 21 CRF Part 11 compliant computer systems
Adequate experience in backup & recovery tools such as VMware, Acronis & Robocopy
Lab cots System –it support GMP.
Thanks,
_______________________________________
Govind Singh Kushwah | New York Technology Partners
120 Wood Avenue S | Suite 504 | Iselin NJ 08830
Direct: 201.604.3877 | www.nytp.com | Join me on LinkedIn
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