Overview
Remote
On-site
Compensation
$75-$90/hour
Job Description
Our Client, a Clinical-Stage Biotechnology company, is looking for a Computer and Equipment Validation for their Newark, CA location.Responsibilities:
- Periodic Review: Coordinate and support routine periodic system reviews
- Validation: Author or support development of system lifecycle documents (e.g. risk assessments, user requirement specifications, test protocols)
- Qualification / Testing: coordinate, manage and/or execute test protocols (e.g. OQ, UAT), address exceptions, and review completed test packages.
- SDLC Support: support business owners, system owners, and other stakeholders through required system lifecycle activities.
- Data Integrity: Coordinate and support data integrity assessments
- Compliance: ensure relevant electronic record, data integrity and other compliance requirements are defined for new systems per Allogene procedures and regulatory expectations.
- Change Control: Lead or support the system change control process as required
- Supports and troubleshoots complex system issues
- A minimum B.S. degree in a scientific discipline is required
- Minimum 6-8 years’ experience in qualifications/validations in the pharmaceutical or related industry
- Must have CSV and/or CSA experience
- Previous experience in ERP, LIMS, MES and/or DMS system validation is required
- Technical writing
- Sound understanding of regulatory requirements and industry guidelines (21 CFR Part 11, GAMP 5, MHRA Data integrity guidelines, etc.)
- Experience with managing high-volume change control process, SAP change management a plus
- Experience of performing risk and change based impact assessments
- Experience with developing test strategies and designing right-sized test plans/protocols
- Must be able to independently organization, problem solve, multitask and prioritize work
- Work independently, escalate project issues and deliver results within established timelines.
- Health Benefits
- Referral Program
- Excellent growth and advancement opportunities
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FAQs About Computer And Equipment Validation Jobs at Iconma
What is the work location for this position at Iconma?
This job at Iconma is located in Newark, CA, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Iconma?
Candidates can expect a pay range of $75–$90 per hour for this role.
What employment applies to this position at Iconma?
The employer has not provided this information. This may be discussed during the hiring process.
What is the process to apply for this position at Iconma?
You can apply for this role at Iconma either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.