GxP Systems Engineer

GxP Systems Engineer at Transcend Softech LLC GxP Systems Engineer at Transcend Softech LLC in Berlin, Massachusetts Posted in about 23 hours ago.

Type:

full-time

Job Description:

Position:

GxP Systems Engineer Location:

Norwood & Marlborough, MA Long Term Contract The Role Client is seeking a GxP Systems Engineer, who will be responsible for the design, deployment and management of our expanding portfolio of first-in-kind automation and digital enterprise instrumentation systems that support the Quality Control GMP laboratories and system integration with our connected Digital platforms. This role will be a member of the Digital Quality team and requires both strong intellectual agility and hands-on technical skills.

Responsibilities:

Collaborate with a team of internal and external business analysts and other software/automation engineers in the complete product lifecycle management of various Digital Quality Automation Systems (Hamilton Venus, Scitara DLX, etc.) and Standalone Analytical Instrumentation (SpectraMax M5, Hamilton Liquid Pipetting systems, etc.) including implementation, optimization, support, maintenance updates and version upgrades. Translate system/equipment/data integration requirements from various Digital and Business teams to be able to deploy the appropriate Digital Lab System solution in a GMP environment. Manage or assist in necessary change control/regulatory Digital documentation (living documents, SOPs, work instructions, KB articles, etc.) required to demonstrate appropriate compliance. Partner with digital stakeholders to ensure successful validation and integration of key systems into the connected instrument pipeline, future robotics/automation capabilities, and any artificial intelligence initiatives. Minimum Qualifications Bachelor's degree or equivalent in science, engineering or computer science 5 to 7+ years' experience designing, implementing, and managing life sciences Analytical Instruments in a in biopharmaceutical GMP environment Direct experience with automation solutions such as Hamilton Venus preferred Experience with Linux Ubuntu SUDO commands a plus Experience with GAMP and GxP compliance regulations Experience in laboratory systems including data integrity regulations, instrument integration, and laboratory digital workflow optimization Experience working with Digital systems hosted in cloud and understanding of connectivity between on-prem systems and SaaS/Cloud.