GxP Application System Administrator

Seeking a highly experienced GxP Application System Administrator to provide application support of manufacturing, laboratory, and automation systems. 6+ month

CONTRACT

role with potential to extend. Hybrid (3 days/week onsite work required n Lexington, MA) Must have in-depth experience administering GxP-regulated computerized systems. On-call Support will be Minimal, as required to support critical operations. Pay rate range $ 80.00-$95.00/hour, depending upon experience. Lenox Executive Search is seeking an experienced GxP Application System Administrator to fill a 6+ month extendable contractual role with a global pharmaceutical company in Lexington, MA. Must have strong understanding of Data integrity principles (ALCOA+), Change control and CAPA processes (TrackWise), as well as Computerized System Validation (CSV.)

REQUIREMENTS

for the

GxP Application System Administrator:

Must have in-depth experience (2+ years) administering GxP-regulated computerized systems Working knowledge of:

DCS/SCADA

systems (e.g., DeltaV, Rockwell FactoryTalk, Metasys), Historian systems (e.g., PI) and Laboratory and analytical systems (e.g., LabX, Sartocheck 5, Unicorn, ThinManager, Nova Biomass)

Understanding of:

Data integrity principles (ALCOA+), Change control and CAPA processes (TrackWise) and Computerized System Validation (CSV)

RESPONSIBILITIES

of the

GxP Application System Administrator:

Maintain systems in a qualified and validated state Execute system maintenance activities, including patch coordination, system health checks, and backups Ensure systems remain in a secure and controlled state with appropriate documentation and governance Administer user accounts, roles, and permissions in accordance with site procedures Support periodic access reviews and audit activities Investigate and resolve access-related issues (e.g., account lockouts) Respond to and troubleshoot system incidents and user-reported issues Support root cause investigations and deviation/CAPA activities Execute system changes in accordance with approved change management processes Maintain configuration documentation and system inventories Support lifecycle activities including upgrades, patching, enhancements, and decommissioning Ensure backup processes are operational, monitored, and validated Maintain system administration logs and records of activities Ensure documentation is complete, current, and audit-ready Perform periodic system reviews

Pay:

$80.00 - $95.00 per hour

Experience:

administering GxP-regulated computerized systems: 2 years (Required)

DCS/SCADA

systems : 2 years (Required) Historian systems : 2 years (Required) Laboratory and analytical systems : 2 years (Required) ALCOA+: 2 years (Required) Cange control and CAPA processes (TrackWise): 2 years (Required) Computerized System Validation (CSV): 2 years (Required) Ability to

Commute:

Lexington, MA 02420 (Required)

Work Location:

Hybrid remote in Lexington, MA 02420