The opportunity
This Systems Qualification Engineer will support the equipment engineering team with Commissioning Documents, Qualification Documents and Project Management in a demanding environment that requires dynamic problem-solving to meet tight deadlines.
How you’ll spend your day
All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.
Assists in developing recommendations for enhancing the GMP production process.
Tracks project deliverables on directly assigned projects.
Develops Requests for Proposals (RFP), User Requirements (URS), Functional Specifications (FS) and Design Specification (DS) documents.
Develops and Executes control system qualification documents including Installation Qualifications (IQ), Operational Qualifications (OQ) and Performance Qualifications (PQ)
Manages and develops cross-functional Computer Systems Validation (CSV) deliverables for senior technical managers with guidance from team leads, skilled engineers, and RA/QA leads, including:
preparing CSV documentation (IQ, OQ, PQ) including validation plans, test plans, execution results, deviations, corrective actions, summary reports, and other items as directed.
Interfaces with vendors during the design and implementation of control systems.
Supporting team efforts for test executions, deviation resolution, and process improvement Initiatives.
Driving proactively documents submitted into formal workflows.
Being available as needed, on-site, with scheduling flexibility and determined commitment to meeting set deadlines.
