Job Description:
The ultimate purpose of technology teams in GxP environments is to serve the evolving needs of the business.
We are a specialist provider of consultancy and implementation services for IT infrastructure and data architectures within life science manufacturing.
Our role is to be a companion on the road for technology teams to be able to use as a tool at times when decisions need to be made.
Role Summary:
This is a full-time hybrid role as a Validation Engineer at Oleson.
The primary responsibility of the Validation Engineer is to perform day-to-day tasks related to RTL design, debugging, good manufacturing practice (GMP), validation, and functional verification.
Detailed Responsibilities:
* Generation and execution of validation protocols and reports (including IQs, OQs, PQs, QAPs, etc.).
* Lead and/or support validation projects and activities on site, as directed and as appropriate.
* Prepare validation plans in line with the strategic goals of the client and manage timely and compliant delivery of the plan.
* Commissioning and validation of various new processes, technologies, and new equipment.
* Create, review, and approve various quality documents and test data.
* Manage validation exception events and change control processes.
* Develop and execute Commissioning & Qualification lifecycle protocols as per the specific project requirements.
* Support and represent the technical quality team in meetings, visits, troubleshooting exercises, and audits.
* Generate validation investigations and implement corrective actions.
* Provide continuous improvement for existing validation procedures.
Requirements:
* Science / Engineering Degree and 3 years plus relevant validation experience in a GMP environment.
* Experience in executing multiple projects and participating on cross-functional project teams.
* Organizational skills for concurrent execution of multiple equipment/instrument, facility, and utility qualifications and projects.
* Excellent initiative, decision-making, and ability to work in a core team environment attaining resolutions.
* Performance and results-driven.
About Us:
Oleson is a technology strategy & transformation practice.
We are uniquely focused on IT/OT systems in manufacturing operations with a particular strength in regulated life sciences manufacturing.
Our strength is in taking a full system view and understanding the complex relationships between manufacturing operations, business continuity, IT infrastructure, compliance & change control, and system lifecycle planning.