Validation Engineer

Job Title:

Validation Engineer / Specialist (Level II)

Job Description

This full-time Level II Validation Engineer/Specialist role supports commissioning, qualification, and validation activities within the life sciences industry. The position works as part of a project team to develop and execute validation deliverables, ensure compliance with industry and customer requirements, and support multiple concurrent projects in a regulated environment.

Responsibilities

* Develop a strong understanding of how to apply technical, quality, and scientific principles to meet industry standards and customer requirements.

* Work collaboratively in a team environment to achieve defined project objectives within established timelines.

* Develop verification and qualification deliverables, including Requirements Documents, Functional Specifications, Design Specifications, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) protocols, and Summary Reports.

* Execute test protocols accurately and thoroughly, including identifying, documenting, and supporting the resolution of non-conformances and deviations.

* Track and manage change control activities for multiple concurrent projects to ensure proper documentation and compliance.

* Support change and deviation management processes by maintaining clear records and communicating status to project leaders and stakeholders.

* Collaborate with project leaders and other team members to ensure validation activities align with project goals and regulatory expectations.

* Interact confidently with clients, contractors, and colleagues to gather information, clarify requirements, and provide status updates on validation activities.

Essential Skills

* BS/BA degree in a relevant scientific or engineering discipline.

* 1-2 years of experience in the pharmaceutical or other regulated industry directly related to pharmaceutical validation.

* Experience with change and deviation management in a regulated environment.

* Hands-on experience developing and executing validation protocols, including IQ, OQ, and PQ.

* Demonstrated ability to prepare and review validation documentation such as Requirements Documents, Functional Specifications, Design Specifications, and Summary Reports.

* Strong interpersonal skills with the ability to interact confidently with clients, other contractors, and employees.

* Excellent oral and written communication skills.

* High attention to detail and strong documentation practices.

* Experience with change controls and related qualification activities.

Additional

Skills & Qualifications

* BS degree in Biomedical Engineering, Chemical Engineering, or Mechanical Engineering preferred.

* Experience with cleaning, sterilization, and decontamination validation preferred.

* Experience with device assembly and packaging processes preferred.

* Prior experience working on multiple concurrent projects in a regulated life sciences environment.

* Familiarity with industry standards and regulatory expectations for commissioning, qualification, and validation.

* Interest in professional development and expanding skills in new services and geographical areas.

Work Environment

The role operates within a highly regulated life sciences environment focused on commissioning, qualification, and validation activities. You will work as part of project teams led by a Project Leader and report to a Site Manager, collaborating closely with colleagues, clients, and other contractors. The position involves creating and executing validation protocols such as IQ, OQ, and PQ, managing change controls, and handling documentation in accordance with industry and customer requirements.

The company is 100% employee-owned, offering an Employee Stock Ownership Plan (ESOP) and emphasizing professional growth through ongoing development opportunities and expansion into new services and regions. Work is typically structured around project timelines and milestones, requiring strong organization, clear communication, and consistent adherence to quality and compliance standards.

Job Type & Location

This is a Permanent position based out of Portage, MI.

Pay and Benefits

The pay…