Location: Pittsburgh,PA, USA
Job Title: QCA System Engineer I
Location: Hybrid (3 days on-site per week) – Pittsburgh, PA
Employment Type: Contract or DH
Overview: We're seeking a QCA System Engineer I to take operational ownership of quality control application systems, including Laboratory Information Systems (LIMS), instrumentation systems, and environmental systems. This role involves leveraging life sciences expertise to support system lifecycle activities such as integration, maintenance, and system retirement, contributing to a high-performing, regulated environment.
Key Responsibilities: Serve as platform owner throughout the Systems Development Lifecycle (SDLC).
Author functional specifications, configuration documents, and commissioning records.
Configure workflows or program systems (e.g., LIMS Basic, SQL, Python) to meet operational needs.
Support validation activities, including installation (IQ), operational (OQ), and performance qualifications (PQ).
Function as a system administrator for applications.
Develop reports for data trending and quality analysis.
Ensure data integrity, system performance, and adherence to FDA GxP regulations and ISO standards.
Collaborate with stakeholders to ensure systems align with requirements.
Stay updated with ISPE GAMP best practices.
Required Qualifications:
Bachelor's degree in Bioengineering, Life Sciences, or a related field. Alternatively, 6+ years of direct experience with systems such as LIMS, enterprise asset management, or environmental systems.1–3 years of experience with LIMS, clinical research/trials, or automated process monitoring/control systems. Basic understanding of cGMP and 21 CFR Part 11 regulations. Knowledge of SQL and programming languages like Python. Strong problem-solving, analytical, and critical thinking skills. Effective verbal, written, and interpersonal communication skills.
Preferred Qualifications: Background in life sciences (biology, chemistry, bioengineering, etc.). Experience in FDA-regulated environments, pharmaceuticals, or biotech. Familiarity with debugging and enhancing vendor-provided software solutions. Ability to work independently and handle ambiguous situations. Work Environment: Office setting with minimal travel (Must be comfortable working with hazardous chemicals and disinfectants in a BSL-II environment. May require extended hours to meet deadlines.
Why Join Us?This role is ideal for candidates passionate about integrating life sciences with advanced technology to drive quality and compliance in a regulated environment. If you thrive on solving complex challenges, supporting critical systems, and collaborating with a dynamic team, we'd love to hear from you!