Equipment Validation Engineer

Apex Systems; Indianapolis (IN); On-site; USD 70,000 - 95,000; Full time

Job summary

An established industry player is looking for an Equipment Validation Engineer to join their team in Indianapolis. This long-term contract role involves on-site support and focuses on ensuring compliance with quality standards in the Life Sciences sector. You will be responsible for implementing and monitoring validation processes, managing documentation, and supporting quality improvement initiatives. If you have a strong background in Quality Assurance and a passion for ensuring operational excellence, this is an exciting opportunity to contribute to impactful projects in a dynamic environment.

Qualifications

• 3+ years of experience in Quality Assurance or Validation in regulated industries.
• Experience with non-conformance and change control processes.

Responsibilities

• Implement and monitor processes for compliance with industry guidance.
• Manage documentation and training programs for validation.

Skills

Quality Assurance

Validation Lifecycle (IQ, OQ, PQ)

Regulatory Compliance

Documentation Management

Communication Skills

Education

Bachelor’s in Life Sciences

Tools

SmartLab

SmartSheet

GMARS

Job description

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Job Details:

• Role: Equipment Validation Engineer
• Location: Indianapolis, IN (On-Site)
• Type: Long Term Contract

Apex Systems, a global leader in Technology Services, is seeking an Equipment Validation Engineer in Indianapolis, IN, for a large Life Sciences client. This is a long-term contract with an immediate start. The role requires on-site support 5 days a week due to its nature.

Duties and Responsibilities:

1. Support implementation, maintenance, and monitoring of processes to ensure compliance with relevant guidance.
2. Retire, move devices, and follow Qualification processes.
3. Experience in IQ, OQ, and PQ within the Validation lifecycle.
4. Manage documentation, record control, and archiving activities.
5. Manage training and competency programs.
6. Track, monitor, and present operational and quality metrics.
7. Support quality improvement initiatives and corrective actions.

Minimum Education and Experience:

• Bachelor’s in Life Sciences or equivalent, with 3+ years of related experience.
• 2+ years in Quality Assurance, Auditing, or Validation in regulated industries like Pharma, Biotech, Medical Devices.

Preferred Qualifications:

• Experience with non-conformance, change control, and risk management.
• Knowledge of accreditation standards, GCP/GCLP, and 21 CFR Part 11.
• Ability to interpret regulations and technical documents.
• Strong communication skills for multi-disciplinary teams.
• Familiarity with Quality Metrics, GMARS, SmartLab, and SmartSheet.
• Ability to work independently in a fast-paced environment.

Note: The description contains extensive information about company benefits, equal opportunity employment policies, and additional job postings, which are relevant but can be summarized or omitted for conciseness in some contexts.