Change Control Engineer

Alliance Group Technologies Inc; Indianapolis (IN); Hybrid; USD 75,000 - 90,000; Full time

Job summary

A leading company in Pharmaceutical Manufacturing is seeking a Change Control Engineer to support the implementation of a new IT tool, Veeva QMS. This role involves participating in design, testing, and training phases to standardize quality processes across the organization. Ideal candidates will have a Bachelor’s in Engineering and experience with change management processes, including GMPs.

Benefits

Medical insurance

Vision insurance

Qualifications

• Experience with change control processes required.
• Previous experience supporting GMP activities preferred.
• Ability to work on-site primarily with flexibility for remote work.

Responsibilities

• Serve as the Engineer on the Change Control Core Team.
• Participate in the design, testing, and validation of system changes.
• Develop and refine procedures and training materials.

Skills

Authoring change controls

Knowledge of GMPs

Process automation

Education

Bachelor’s degree in Engineering or similar

Tools

Veeva QMS

TrackWise

ServiceNow

IBM Maximo

Job description

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Overview

The overall project seeks to standardize Quality-related business processes across the enterprise. For some processes, including Change Control, we are also implementing a new IT tool, Veeva QMS, as a replacement for our current system, TrackWise. I am seeking a Change Control Engineering resource to support this project

• The Change Control implementation team for QMS consists of a cross-functional Core Team. I am looking for a resource to serve as the Engineer on the Core Team. The Core Team participates in the design and testing of the Veeva Change Control configuration, serves as a subject matter expert for procedure and training development, executes testing during the system validation, and supports users during the system go-live and stabilization period.
• Anticipated Timeline & Responsibilities
• The responsibilities will vary depending on the project phase.
• July – September 2025: this is the build/configure phase of the project. The Change Control Engineer will spend time shadowing the current client Engineer on the Core Team, who will be available until September but is then rolling off the project. During this period, the Engineer will attend team meetings and requirements gathering sessions, execute informal testing of the system (called Process Exercises), give feedback on the configuration of the system, report issues, and retest after configuration changes have been made. I also expect the Engineer to be learning the current change management processes by observing and making connections with other client Engineers who are change management practitioners. In this and future phases of the project, the Engineer will represent the interests of the Engineering function in terms of needs in the change control process, understand existing pain points, and bring best practices to the project team to be incorporated in the new global process.
• September 2025 – January 2026: during this period, we will be developing procedures and training and executing validation of the new system. The Engineer will be the SME responsible for one or more procedures/required tools in the global process. He/she will work in conjunction with our business integrator to develop and refine these SOPs/required tools. Additionally, he/she will serve as the SME for the related training assets. Training will be developed by clients team, and the SME will be their primary point of contact for providing the source materials (SOP, required tools, other resource documents), consulting on questions related to the content, and gathering and evaluating review comments. During the validation activities, the Engineer will execute designated test scripts and document results according to client procedures. Test scripts will be developed by the business integrator.
• January – March 2026: during this period, end user training will be occurring. The Engineer will participate in the training of power users and will respond to questions from end users during the training period.
• Go live is scheduled for two waves, one in early March and one in mid-April 2026. The Engineer will support questions from end users during each go-live and stabilization period that follows.
• Technical skills and experience required
• Engineering or similar Bachelor’s degree
• Experience with authoring and executing change controls
• Basic working knowledge of key engineering functions: maintenance and reliability, equipment commissioning and qualification, process automation, and process monitoring
• Knowledge of current Good Manufacturing Processes (GMPs) and previous experience supporting GMP activities
• Experience with global maintenance and reliability systems (GMARS, clients implementation of the IBM Maximo system ) and IT-related change systems (such as ServiceNow) is a plus
• Previous experience with Veeva QMS or TrackWise is a plus
• Work location and travel

Preference would be for the candidate to be able to work primarily onsite in Indianapolis. However, the team is not co-located 100% of the time, so there is an opportunity for some work to be performed remotely. There are some designated activities where the Core Team, Business Integrator, and software developer (Veeva) will be co-located in Indianapolis. This would include requirements gathering workshops, testing windows, and power user training sessions. Additional time onsite may be needed while learning existing change control processes.

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Industries

  Pharmaceutical Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

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