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Verista

GxP lifecycle consulting for life sciences

Senior Project Engineer

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeColumbus, OH, USAIn-person

About the Job

Requirements

  • At least 5 years of experience in equipment engineering, commissioning, qualification, validation (CQV), automation, manufacturing engineering, or a related discipline.
  • Strong hands-on experience with automated manufacturing and packaging equipment.
  • Demonstrated expertise troubleshooting mechanical, electrical, controls, and automation systems.
  • Experience in a GMP-regulated pharmaceutical, biotechnology, medical device, or similar manufacturing environment.
  • Strong understanding of equipment qualification, commissioning, and validation principles.
  • Proven ability to lead technical issues, vendors, projects, and cross-functional engineering teams.
  • Strong analytical, troubleshooting, communication, and technical documentation skills.
  • Willingness to work second and/or third shift as required.

Responsibilities

  • Lead equipment commissioning, startup, qualification, and performance activities.
  • Provide hands-on engineering support for complex mechanical, electrical, controls, instrumentation, servo, vision, and automation issues.
  • Lead troubleshooting, root-cause analysis, and implementation of corrective and equipment improvement actions.
  • Review and approve equipment designs, specifications, drawings, control strategies, and technical documentation.
  • Lead equipment integration, optimization, and production ramp-up activities.
  • Serve as the technical interface with equipment original equipment manufacturers and vendors, driving issue resolution and equipment performance.
  • Develop and execute engineering and CQV test strategies, including factory acceptance testing, site acceptance testing, installation qualification, operational qualification, and performance testing.
  • Identify opportunities to improve equipment reliability, throughput, cycle time, quality, and maintainability.
  • Provide technical direction and mentorship to junior engineers and CQV personnel.
  • Support deviations, change controls, corrective and preventive actions, and technical investigations within a GMP environment.
  • Provide engineering leadership during off-shift commissioning, qualification, and production support.

Desired Qualifications

  • Experience with programmable logic controller/human-machine interface systems, servos, sensors, vision systems, robotics, and automated equipment.
  • Experience with ATS, IMA, Dividella, or similar equipment.

About the Company

Verista

GxP lifecycle consulting for life sciences

Verista provides business and technology consulting for life science companies, focusing on systems, compliance, validation and quality across the GxP lifecycle. Its services cover preclinical, clinical, commercialization, manufacturing and distribution to ensure safe, high-quality results. The company combines decades of industry knowledge with advanced engagement platforms and transformative technologies to help clients solve complex challenges with one partner across specialties. With a team of 500+ experts, Verista supports clients from strategy and validation to execution, delivering consistent, compliant outcomes that improve health and lives. The goal is to enable better health outcomes by ensuring products and processes are safe, compliant and efficient throughout the product development lifecycle.

Company size
201-500
Company stage
Not listed
Total funding
Not listed
Headquarters
Fishers, IN
Founded
2020

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