Sr. Equipment Validation Engineer
Job in
Lebanon, Boone County, Indiana, 46052, USA
Listed on 2026-07-01
Listing for:
Apex Systems
Full Time
position Listed on 2026-07-01
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist, QA Specialist - Analyst/Manager
Job Description & How to Apply Below
Sr. Equipment Validation Engineer
Location:
Leabanon, IN (On-Site)
Type:
Long Term Contract
Apex Systems, a global leader in Technology Services, is searching for a Sr. Equipment Validation Engineer in Indianapolis, IN for a large Life Sciences client. This is a long term contract with an immediate start date. This role requires on site support 5 days a week due to the nature of the role. See below for more details!
Duties and Responsibilities:- Supports the implementation, maintenance, and monitoring of processes and procedures to ensure departments are in compliance with relevant guidance and requirements.
- Responsible for retiring devices when applicable, moving devices, and following Qualification processes.
- Strong experience in Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) in the Validation lifecycle.
- Experience with "First In Kind" Instruments, and qualification SOPs related to them
- Manage the document and record control and archiving activities.
- Manage the training and competency program.
- Supports the tracking, monitoring, and presentation of operational and quality metrics.
- Initiates or supports quality improvements initiatives to enhance performance and/or mitigate quality or compliance risks, as needed.
- Supports the implementation of corrective actions as a result of audit observations and investigations, as necessary.
Required:
- Bachelor's degree in Life Sciences or equivalent with 3+ years of related experience within the healthcare industry.
- 2+ years relevant experience in areas of Quality Assurance, Auditing, and/or Validation, in regulated industries-preferably in Pharmaceutical, Biotech, Medical device
- Experience in non-conformance events, change control management and risk management.
- Working knowledge of accreditation standards, practice, and guidelines sufficient to guide laboratory operations.
- Knowledge of GCP/GCMP regulations including experience working within 21 CFR Part 11 regulations.
- Ability to comprehend regulations and guidance documents and technical information related to equipment, processes, and regulatory expectations.
- Strong organization to communicate to multi-disciplinary project teams.
- Familiarity with collecting and reporting Quality Metrics.
- Computer literate and familiar with most common software applications (i.e., Word, Excel etc.)
- Working experience with Lab Vantage, Labware, or other LIMS systems.
- Capable of working independently with minimal supervision and interacting with staff in a fast-paced sometimes pressure-filled environment.
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