CSV Systems Engineer II

Job Description: CSV Systems Engineer II/III in Albany, NY

Level will be dependent upon experience

Build your future at Curia, where our work has the power to save lives.

The CSV Systems Engineer will be responsible for supporting Quality Management Systems and Computer System Validation efforts. This role will provide guidance and expertise on various global and site CSV projects to ensure that quality teams have the necessary tools to provide quality metrics, measurements, and reports for internal audits and inspections.

Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives.

We Proudly Offer

• Generous benefit options (eligible first day of employment)
• Paid training, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities
• Education reimbursement
• 401K program with matching contributions
• Learning platform
• And more!

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.