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Verista

GxP lifecycle consulting for life sciences

CQV Engineer

Regulatory & Quality (Life Sciences)Posted on Nov 11
Full-timePortland, ME, USA

About the Job

Requirements

  • A bachelor's degree in Engineering, Science, or a related technical field is required.
  • At least 1 year of experience supporting validation, qualification, or testing activities is required; internship or co-op experience is considered.
  • Experience supporting NPI, tech transfer, or new equipment and line introductions in pharmaceutical, medical device, combination product, or regulated packaging operations is required.
  • Ability to read and interpret technical schematics and drawings, or willingness to learn quickly, is required.
  • GMP and Good Documentation Practice training is required.
  • Proficiency with PC and Microsoft Office tools, including intermediate Word skills for authoring and editing large technical documents using styles, tables, tables of contents, and track changes, is required.
  • Strong problem-solving, critical thinking, attention to detail, organization, and time management skills are required.
  • Strong interpersonal and communication skills, including the ability to explain issues clearly and concisely and work effectively as part of a team, are required.
  • Willingness to work on-site full-time in Portland, Maine, is required.

Responsibilities

  • Author, edit, and execute commissioning, qualification, and validation documentation, including protocols, test scripts, and summary reports, for new equipment, systems, software, and processes introduced for NPI projects, as directed by the project leader.
  • Execute approved test scripts, accurately record results in line with Good Documentation Practices, and document discrepancies for review and resolution.
  • Support installation verification, FAT/SAT, and operational testing of new equipment and line modifications, confirming components against specifications and approved drawings.
  • Support product changeovers and line readiness activities so new products can be introduced on schedule.
  • Maintain clear, detailed, audit-ready qualification and validation records that support NPI launch readiness.
  • Meet the project schedule for assigned activities and communicate progress, risks, and timeline impacts to the project leader.
  • Collaborate with NPI project teams, Engineering, Automation, Quality, and vendors to resolve test issues and keep documentation accurate and current.

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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