A global leader in the Biotechnology space are actively seeking a Systems Engineer II to play a pivotal role within their innovative and technology-centric Quality Control group. With around 16,000 employees globally this firm leverages technological insight to deliver innovative medicines and treat diseases for their network of clients across the Pharmaceutical, Biotechnology and Nutrition sectors.
Responsibilities
- Ensures regulatory requirements and policies pertaining to analytical instruments and computer software applications are met.
- Completes QC analytical instrument and software validation deliverables, writes GMP procedures, validation documents and executes test scripts.
- Provide day-to-day Operations Technology (OT) and infrastructure support (applications, networks, workstations and client devices) for Quality Control.
- Monitor and troubleshoot daily system backups.
- Perform maintenance and repair for operator workstation terminals, label printers, and wireless devices.
- Scripting in PowerShell, Python, and Bash Knowledge with VMware ESX, ESXi, and VSphere environments with vCenter Management.
- Performs all aspects of QMS process' - Change Control, Deviations, CAPAs, Tasks Writes, reviews, assesses, and/or approves change controls for analytical software used in QC laboratories.
Requirements
- Bachelor or Master's Degree, preferred area of study in IT, Engineering or Computer Science
- 3+ years of experience working in Operations Technology (OT) and infrastructure support
- Preferred experience within a regulated cGMP industry
- Professional experience and a high-level understanding of working with various operating systems
- Knowledge of Data Integrity and 21 CFR Part 11
- Preferred Experience with ECM and Corner bowl system is a plus
- Preferred experience scripting in PowerShell, Python, and Bash Knowledge with VMware ESX, ESXi, and VSphere environments with vCenter Management
- Ability to work and communicate in a team environment
Additional Information
- Base salary $80-105k
- Relocation assistance possible
- 3 days / on-site in Portsmouth, NH office