Sr. Equipment Validation Engineer

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Job Description # Sr. Equipment Validation Engineer
* 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.
* 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/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, Smart Lab, and Smart Sheet.
* Capable of working independently with minimal supervision and interacting with staff in a fast-paced sometimes pressure-filled environment.
* Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package.

Our commitment to excellence is reflected in many awards, including Clearly Rated's Best of Staffing(R) in Talent Satisfaction in the United States and Great Place to Work(R) in the United Kingdom and Mexico. Apex uses a virtual recruiter as part of the application process. Click
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