Lab Systems Engineer

Reporting to the Director of Manufacturing IT- you would be the first hire in a newly developed team at an exciting time in the company’s growth. Work closely with the QC team developing process state of the art manufacturing facility to run point to develop process and best practices in this functional and technical support position..

 

What you’ll do-

·        Collaborate with business stakeholders to understand their current and future state requirements.

• Develop and document functional and technical aspects for system-system integrations such as with QC equipment data acquisition
• Assist in business process and system design
• Proactively offer solution ideas and potential business process improvements in pursuit of driving efficiencies and meeting business needs
• Develop test methods, calculation building, product specifications, environmental monitoring, product sampling plans, stability, storage location manager, reagent and instrument management, report builder through the use of LIMS
• Utilize your knowledge of end-to-end QC processes, laboratory data, and instrumentation and how QC labs adhere to GMP regulations.

·        Work closely with Computer Systems Validation and Quality Assurance groups as needed to ensure compliance with GxP regulations and data integrity

 

Qualifications:

• A minimum of 5 years of experience in a pharmaceutical manufacturing environment including use of LIMS (Labware, LabVantage, BIOVIA, MODA) in a functional role.
• Strong process development skills within QC and 1-3 years of technical support of LIMS

 

Location: Post Covid-80/20 split between onsite in their Metro-West facility and remote. Initially requires 50/50 split.