oracle
CSV Systems Engineer II
Albany Molecular Research, Inc.
Albany, USA
Full-time
Senior · 30+ years experience
Onsite
Discovered 3 days ago
Full Job Posting
Responsibilities
- Computer Systems Validation
- Manage multiple site and global CSV projects at any time
- Maintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues
- Create all CSV deliverables for all CSV projects
- Provide expertise in SOP generation and CSV process
- Own general configuration modification to any CSV system based on CSV compliance standards
- Provide expertise on creation of CSV execution templates
- Perform CSV risk assessments
- Quality Management
- Own CSV change records, CAPAs and Quality events for the CSV projects
- Act as CSV reviewer on any CSV defects/deviations within any project
- Support Site and global CSV actions from any audits
- Participate in all site audits/inspections as CSV subject matter expert
- Provide guidance and resolution on quality issues that affect the integrity of the data or the system
- Inventory Management
- Gather inventory and maintain all scientific applications and computer systems within Curia sites (GMP and non-GMP)
- Inform Service Engineer I of any changes in software and hardware status
- IT Compliance
- Support Lab Ops team to ensure all computer systems has up to date Antivirus software
- Support Lab Ops team to ensure all computer systems have a backup software installation
- Support Lab Ops team in updating computer systems that are running outdated Operating systems
- Perform monthly patching auditing risk assessments with Lead CSV Compliance Analyst
- Periodic internal audits and inspections readiness
- Execute periodic reviews and data collection
- Participate in all site audits /inspections as a CSV subject matter expert
- Quality metrics, measurement, and reporting
- Provide routine project status reports
- Provide routine software and hardware inventory updates
- Provide routine progress updates on SOPs and Templates
- Provide CAPA, QE and CR updates to compliance team
- Provide routine audit observations and remediations
- Required
- Bachelor’s Degree in Information Technology or related field
- Minimum 3 years’ experience in quality and computer systems validation and/or information technology
- Preferred
- Experience in the pharmaceutical industry
- Pay Range:
- Education, experience, location and tenure may be considered along with internal equity when job offers are extended.
- We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.
- All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.
Qualifications
- Bachelor’s Degree in Information Technology or related field
About Albany Molecular Research, Inc.
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