Junior Validation Engineer / Decommissioning Specialist
Location: North Chicago, IL - onsite Contract: 15+ months duration, anticipated project completion February 2028 Schedule: Approximately 40 hours per week, subject to client approval
Position Summary
Automated Systems, Inc. is seeking a Junior Validation Engineers / Decommissioning Specialist to support the decommissioning of pharmaceutical fermentation manufacturing equipment, utilities, laboratory equipment, and associated automation systems at our global pharma manufacturing client’s facility located in North Chicago, IL.
In this role, you will be working under the direction of a senior decommissioning lead, these resources will prepare and execute documentation, verify equipment information, coordinate assigned activities, and follow deliverables through review and approval. This position is suited to someone with practical GMP experience, strong attention to detail, and the initiative to keep assigned work moving.
Responsibilities
- Review equipment records, existing qualifications documents, drawings, and applicable procedures to support decommissioning assessments.
- Perform equipment walkdowns and verify asset identification, system boundaries, and relevant equipment information.
- Draft decommissioning protocols and Engineering Change Management documentation using approved procedures and templates.
- Execute approved decommissioning documents, record results accurately, and assemble supporting evidence.
- Coordinate assigned activities with Engineering, Operations, Validation, QA, and system subject-matter experts.
- Support document routing and track review comments, required corrections, and approvals in applicable systems.
- Identify discrepancies, missing information, and execution issues; promptly bring them to the senior lead with supporting details.
- Assist with deviation documentation and resolution.
- Perform technical document reviews within assigned qualifications and responsibilities.
- Maintain accurate task status and provide input for weekly progress reporting.
- Follow GMP, documentation, training, and site safety requirements.
Requirements
Qualifications
- 2+ years of relevant pharmaceutical or biotechnology qualification, validation, or decommissioning experience.
- Experience preparing or executing qualifications and decommissioning documentation for equipment or systems.
- Working knowledge of GMP, good documentation practices, change control, and deviations.
- Degree in engineering, science, or a related technical discipline.
- Ability to follow approved procedures, write clearly, and maintain accurate records.
- Comfortable working in manufacturing and laboratory environments and coordinating with technical personnel.
- Ability to manage assigned tasks independently while recognizing when clarification or escalation is needed.
- Willingness to learn site procedures and respond constructively to technical review comments.
Preferred Experience
- Exposure to fermentation equipment, process tanks, sterilizers, utilities, or laboratory equipment.
- Experience using electronic validation or document management systems, particularly Kneat, OneVault, or OneTrack.