Lab / Production Technician

Job Title : Tech 1, Product Development Engineering

Location : Vernon Hills Illinois 60061

Duration : 12 Months

JOB DESCRIPTION : Onsite 100%

Must Have

Computer skills

Lab experience

Microsoft Applications

Nice to Have

GMP, GDP and GLP

Minitab

Physical test lab experience

Test Method Validation experience

Primary focus of this position is to assist R&D EU MDR and Manufacturing related testing, and associated test adjacent tasks. This would include receiving in, staging, labeling, tracking and prepping test product, trialing test methods to confirm and optimize test steps prior to validation.

Other tasks may include drafting portions of Test Protocols, Test Reports, SOPs, and Work Instructions, performing discovery and feasibility testing and documenting testing in lab notebooks, collecting and entering data, performing independent reviewer activities, supporting testing at outside laboratories, renewing confidentiality agreements, supporting calibration activities, conducting in-person lab safety training to new hires and new to the lab associates, conducting bi-monthly lab inspections, monitoring the Deionize Water system, and coordinating disposal of medical products and sharps with Environmental Health & Safety.

Essential / Key Job Responsibilities :

Testing : Ability to perform testing by following test methods and test protocols from R&D engineers; collecting data and record test results; entering test data into Excel and Minitab, organizing and when needed presenting data and observations to peers and management in a reportable format. Sets up and tears down test equipment for testing per test protocols.

Documentation : Assist in preparation of documentation including test protocols, test reports, work instructions, standard operating procedures, lab notebook studies while complying with GLP, GMP and Quality requirements.

Test Method Development : Review test methods during test method development and assists with test method validations as a test operator. Assist in reviewing and editing existing test methods as needed.

Test Equipment and Fixturing : Assist in maintaining test equipment, fix Turing, and other lab equipment such as the vacuum system.

Training : May provide in-person training on test equipment, test methods, general lab policies and lab safety training to other personnel.

Materials / Inventory : May generate purchase orders for general lab supplies, monitor inventory, coordinate shipping materials / receiving in materials including to / from sterilization, ship testing and conditioning for R&D products.

Audit Support : Assist in preparation for internal and external audits. Activities may include lab cleanup, labeling product, organizing / optimizing lab casework, confirming lab notebook status and inventory, coordinating cleaning of lab countertops with housekeeping, verifying calibrated equipment location and status, and preparing communication to the R&D team regarding audit timing and rescheduling testing if needed.

Fiscal : Comply to budget spend requirements and awareness of the Approved Supplier procedure.

Other Responsibilities may include, however are not limited to :

Assist in the support of Manufacturing, Quality, Regulatory & R&D to ensure systems are compliant with all internal and external guidelines.

Assist engineers in design and process root cause analysis and support non-conforming product and complaint investigations.

Required Qualifications :

Minimum of a High School Diploma / GED. Associates of Science degree in science, math or engineering preferred.

Experience working in a laboratory with knowledge of GMP, GDP and GLP, and an ability to operate lab equipment with practical and technical knowledge of common lab instrumentation and equipment used for testing, is a plus.

Proficiency in computer skills (MS Windows, MS Outlook, Word, Excel and PowerPoint) and ability to enter data in Microsoft Project and / or Minitab for data analysis.

Experience with physical testing tools and equipment (hand tools, force and torque gauges, balances, digital and analog gauges, Zwick (or Zwick-like tensile / compression testers like an Instron) is preferred. Experience with laboratory test equipment is a plus.

Preferred Qualifications :

Experience in executing test method validations.

Ability to analyze test data and recommend actions; has practical and technical knowledge of root cause and statistical methods and analysis.

Ability to optimize test methods utilizing problem solving and critical thinking. Has general technical awareness and amplitude and an ability to read and understand technical specifications and reports (e.g., drawings, flowcharts, operation and maintenance manuals, and directions for use).

Interpret and understand statistical analysis reports.

Education and / or Experience :

Minimum of a High School Diploma / GED. Associates of Science degree in science, math or engineering preferred.

Experience :

Minimum 0-3 years of industrial experience in R&D or process development, or Associates of Science degree in science, math or engineering. Preferred, 1-2 years related experience preferably in medical device or other regulated FDA / QSR and ISO environment.