Equipment Validation Engineer

Apex Systems, a global leader in Technology Services, is searching for an 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.
• 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.

Minimum Education and Experience 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

Preferred Qualifications:

• 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/GCLP regulation including knowledge of 21 CFR Part 11.
• 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 GMARS, SmartLab, and SmartSheet.
• Capable of working independently with minimal supervision and interacting with staff in a fast-paced sometimes pressure-filled environment.

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.