URGENT - Labware - Computer Systems Validation Engineer: Indigeny

Founded in 2002, Indigeny Corporation is an established IT Services Firm that is focused on delivering top-quality IT solutions to the Life Science Industry. We enable our clients to develop processes that help them develop drugs faster, manufacture products more efficiently, connect their customers to their brands and sales channels more effectively, and enable hospitals and physicians to relate with their patients faster, easier and more openly. We have an enviable client base and offer a healthy and rewarding working environment.

Due to an increase in demand for our consulting services, we are currently seeking to appoint software engineer(s)/validation engineer(s) with Scientific Systems technology and validation experience within the Life Science industry in a GxP environment.

Required Experience:

• BS/BA Degree. Advanced degree a plus
• Minimum of 4 years relevant industry experience performing testing and system engineering (development & testing) work with scientific systems
• Minimum of 3 years experience in computer systems validation including scientific systems.
• Validation experience must include
  • Authoring validation plans
  • Authoring of IQ/OQ/PQ
  • Execution of IQ/OQ/PQ activities
• Understands GMP and GxP IT Scientific systems requirements
• 2 years of application support for GxP systems
• Understanding/Support and Validation of laboratory systems and chromatography
• Expert knowledge of 21CFR Part 11, audit trails, security features, cGMP, GCP & regulatory requirements for automated systems
• Excellent communication skills
• Proven ability to handle (and thrive on) accountability
• Demonstrated ability to communicate effectively throughout all levels of an organization

Pluses:

• 2+ years administration experience with any of the following: Labware LIMS, SQL* LIMS, Waters Empower (previously Millennium) Chromatography System (system administration, user administration, maintenance, upgrade, etc.)
• Hands-on validation of scientific systems - LabWare LIMS
• Hands-on knowlege and validation experience with Stability module for LabWare LIMS is a significant plus.
• Scientific experience in laboratory environment and/or hands-on experience with other scientific or life-sciences computer systems

For local candidates, we offer FT roles with full benefits. For non-local candidates, we offer competitive rates and expenses for travel.