CSV Systems Engineer II

Job-:
Information Technology

Location:

Albany, NY, United States

Schedule:

Full time Posted:

Shift: Day Relocation Eligibility:
Yes Quality

Requisition :
No

Vault Access: TBD

Job Description:

CSV Systems Engineer II/III in Albany, NYLevel 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 statusIT 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…