Valspec3mo ago

Equipment Validation Engineer

Non-Headquartersmid

Engineering

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Quick Summary

Overview

Technical Tools

Engineering

Valspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec’s mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle maintenance goals.

Valspec’s projects are critical to the industry, and to the people who rely on its products. Many projects ensure that life-changing drugs are available to those who need them; others streamline production to meet demand at a lower cost, allowing for the discovery of new and innovative therapies.

We are seeking a highly motivated and detail-oriented GMP Equipment Validation Engineer to support Commissioning, Qualification, and Validation (CQV) activities for a range of manufacturing and utility equipment at a client site. This role is ideal for someone who thrives in a dynamic environment, can work independently, and is confident interfacing directly with client teams.

Our CQV team collaborates closely with the client across multiple facets of controls and automation, ensuring seamless integration and compliance with regulatory standards. The ideal candidate will bring strong technical expertise, excellent communication skills, and a proactive approach to problem-solving. The ideal candidate has experience leading the equipment CQV efforts of a team that also includes computer system validation engineers and specialists.

Responsibilities

~1 min read

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Lead and execute CQV activities for GMP equipment including:
- →Autoclaves
- →CIP/SIP systems
- →Bioreactors
- →Incubators
- →Freezers
- →Refrigerators
- →Centrifuges
- →Washers
- →Controlled temperature units
- →Environmental chambers
- →HVAC systems
- →Clean steam generators
- →WFI systems
- →Process tanks
- →Utility systems (compressed air, nitrogen, etc.)
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Develop and review validation documentation including URS, DQ, IQ, OQ, and PQ protocols and reports.
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Perform risk assessments and impact analyses to support validation strategy.
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Coordinate with client engineering, automation, and quality teams to ensure alignment on project goals and timelines.
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Troubleshoot and resolve equipment and process issues during commissioning and qualification phases.
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Maintain compliance with cGMP, FDA, and other applicable regulatory requirements.
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Provide timely updates and communicate effectively with client stakeholders.

Requirements

~1 min read

Bachelor’s degree in engineering, Life Sciences, or related field.
3+ years of experience in CQV within a GMP-regulated environment.
Strong understanding of validation lifecycle and regulatory expectations.
Experience with automated systems and controls integration is a plus.
Excellent organizational and communication skills.
Ability to work independently and manage multiple priorities.

This is an excellent opportunity for anyone who can be onsite in NEPA and lead equipment CQV efforts, along with another team that is performing computer system validation. We will need others to be staff validation engineers in the future as well, but this is for someone who can work independently and provide some leadership on the technical side. Apply if interested.