What are the responsibilities and job description for the Validation Engineer position at Techlink Systems?
Job Title: Validation Engineer
Location: Lake Forest, IL (Onsite)
Contract Duration: Until January 19, 2026
Working Hours: 8:30 AM – 4:30 PM
Job Description
This is a non-exempt position requiring independent work under limited supervision. The Engineer performs highly complex software project activities in areas such as Development, Tools, Tests, and Requirements. Responsibilities may include:
- Analyzing requirements and maintaining software specifications.
- Planning and scheduling data based on project needs and improvements.
- Troubleshooting, debugging, and maintaining software, tests, and tool designs.
- Acting as a project team lead and supervising other engineers as needed.
- Applying theoretical engineering principles and creative/analytical techniques to resolve technical issues.
Key Responsibilities
Software Development
- Develop, maintain, and update design and interface specifications from requirement specifications.
- Implement, enhance, and modify software source code, scripts, and procedures.
- Troubleshoot and debug software problems; offer strategic solutions for future development.
- Write, update, and maintain requirements and interface specifications.
Testing & Validation
- Develop, maintain, and update test requirements, designs, cases, and procedures.
- Execute tests and report results.
- Identify test parameters and critical components.
- Contribute to root-cause analysis of failures and create risk/hazard analysis specifications.
Collaboration & Reviews
- Present at design reviews and resolve documented issues.
- Participate in reviews of project deliverables, ensuring feasibility, accuracy, and completeness.
- Contribute to test-phase efforts and provide feedback to peers on related projects.
Compliance & Communication
- Adhere to FDA regulations, Quality Management Systems (QMS), and Environmental Management Systems (EMS).
- Support company initiatives as directed by management.
- Maintain positive and collaborative communication with employees, customers, contractors, and vendors.
Other Responsibilities
- Perform additional duties as assigned by management.
Qualifications
Minimum Education/Experience:
- Bachelor’s degree with at least 8 years of experience, or Master’s degree with 5 years of experience in software engineering, computer science, or a related field.
Top 5 Skills/Requirements:
- Prior experience in regulated industries working with GxP systems.
- Strong knowledge of FDA regulations, including 21 CFR Part 11, 820, Annex 11, GAMP5, ISO 13485, and ISO 27001.
- Proficiency in Quality Management Tools and Test Management Tools such as TrackWise, ComplianceWire, Veeva, ALM, and JIRA.
- Knowledge of Data Integrity principles and experience with audit support (internal and external).
- Experience working with Software as a Service (SaaS), Infrastructure as a Service (IaaS), Platform as a Service (PaaS), Commercial-off-the-shelf (COTS), and custom applications.
Additional Skills:
- Strong organizational and communication skills, with the ability to multitask and prioritize effectively.
- Experience in a matrixed and geographically diverse environment.
- Ability to travel approximately 10%, including internationally.
Interview Preferences:
- Video interviews are preferred.
Salary : $40 - $60
