Engineering Technician II

AT LIFENET HEALTH, YOU ARE THE ADVANTAGE

Every day, YOU help us to save lives, restore health, and bring hope to patients and families around the world. At Life Net Health, we cultivate growth, innovation, and collaboration, where your contributions drive solutions that benefit humanity.

Together, we are united by a mission greater than ourselves, a purpose rooted in healing.

ABOUT THIS JOB

Location:

Virginia Beach, VA (on-site)

Department:
Tissue Engineering

Schedule:

Full-Time, Monday - Friday, 8:15 a.m.

- 5:00 p.m. (ET)

Clinical Status:
Clinical

HOW YOU'LL MAKE AN IMPACT

The Engineering Technician II works within a team on the design, development, optimization, and/or introduction of new processes and equipment. Supports or leads continuous improvement projects and quality investigations. Provides technical support for setup, operation, troubleshooting and maintenance of automated machinery/mechanical equipment. Provides technical process support and executes engineering studies, equipment qualifications, and/or process validations. Performs administrative tasks within engineering department.

Collects and analyzes data to create technical reports.

Your work will have purpose every single day, contributing directly to life-changing outcomes.

WHAT YOU'LL DO

* Plans, initiates, and executes technical functions as part of engineering activities for product and process development design, setup, and implementation of production equipment and processes as well as setup of engineering equipment. Leads troubleshooting of engineering and production equipment. Collects and analyzes data to produce technical reports. Works on or leads LEAN or Continuous Improvement projects.

* Authors and executes technical protocols for feasibility studies, process characterization activities and/or process improvement activities. Author and execute protocols for Equipment Qualification/Requalification (IOQ) and Process Validation (OQ, PQ) in accordance with cGMP and GDP standards.

* Creates or Revises Design and Development Documentation or Standard Operating Procedures (SOPs) in accordance with quality and regulatory standards. Coordinates and oversees the processing of associated Change Orders and training activities in accordance with LNH SOPs and systems. Trains Operations staff on critical or significant SOP changes including updates relating to equipment, processes, or inspection methods to ensure successful implementation.

Performs periodic audits of Operations staff to ensure effectiveness of training and adherence to defined procedures.

* Leads equipment and process-related non-conformance investigations (NCIs) or customer complaint investigations and associated activities such as compiling data to support investigation, executing studies to confirm root cause, implementing corrective actions, and monitoring improvements.

* Authors Quality System documentation to support engineering functions including purchase requisition forms, equipment onboarding forms, calibration forms, preventive maintenance forms, and engineering change orders. Collaborates with other departments to ensure timely and effective execution of changes.

* Collaborates with other Life Net Health departments to support needs as determined appropriate.

WHAT YOU'LL BRING

Minimum Requirements:

* High school diploma or GED and three (3) years of relevant previous technician experience in a product development, scientific, or manufacturing environment OR

* An Associate's degree in Engineering or Technology or the equivalent in vocational training and two (2) years of relevant previous technician experience in a product development, scientific, or manufacturing environment OR

* A Bachelor's degree in Engineering or Technology

Preferred Experience /Skills/

Certifications:

* Four (4) years of experience in tissue/regulated processing within a Good Manufacturing Practices (GMP) environment.

* Lean Certification:
Green belt or similar certification through Life Net Health program or an ANSI National Accreditation Board approved organization.

* Professional Certification: CCT, CQI, CQT, CQA or similar (Certified Calibration Technician, Certified Quality Inspector, Certified…