LEAD VALIDATION ENGINEER

(AUTOMATION, INFORMATION & OPERATIONS TECHNOLOGY SOLUTIONS)

We are looking for tech savvy professionals with a proven track record in the SDLC (system development life cycle) of automated computer systems within biopharmaceutical environments. Due to our unique approach in meeting the demands of our customers, we are pursuing both individuals that can join our team long term as well as SMEs (subject matter experts) that would like to join us on a consulting basis.

Overview

This role supports the execution of small projects or portions of larger projects. Supports the generation of quality assurance plans, verification plans, validation plans, and standard operating procedures as well as conduct risks assessments and participate in Quality/Regulatory audits. Develops and executes qualification protocols and final summary reports and may participate in commissioning activities.

Requirements

• 8 years of Computer System Validation (CSV) experience with process control, SCADA and automation systems, MES and data integration systems (Emerson DeltaV, Syncade / Rockwell PLC, PlantPAx, PMX / Siemens S7, Opcenter Execution Pharma / and/or Honeywell Experion, OSI PI experience is highly preferred)
• Experience with the commissioning and qualification of automation and related systems within virtual and production cGMP environments.
• Direct experience developing validation protocols and execution of protocols.
• Experience creating validation master plans and performing risk assessments.
• Knowledge of current industry standards such as GAMP5 and ASTM E2500.
• Passionate about leading and mentoring others.
• Tactical thinker with experience working with customers developing testing, validation and/or quality strategies.
• Excellent client communication skills.