R&D Laboratory Technician II

Fresenius Medical Care•Ogden, UT

About The Position

The R&D Laboratory Technician II assists with developing innovative products for patients with End Stage Renal Disease (ESRD). Work may include testing chemical, biological, and physical characteristics or compositions of materials for quality control, process control, or product development. The technician performs moderately complex tasks to improve existing products and develop new products and processes, conducting experiments with limited guidance and supervision. For the VS Bloodlines and Concentrates addendum, responsibilities also include supporting product-family phase-gate and product documentation, Design History Files or dossiers, migration of legacy documentation into electronic systems, requirements management, and submission of product documents and change requests through electronic systems. Critical deliverables include timely, accurate, and compliant documentation under applicable design-control, change-control, and good manufacturing practice requirements. The position involves laboratory and plant work, use of personal protective equipment, and occasional exposure to laboratory hazards and potentially hazardous materials. Occasional travel may be required. Reasonable accommodations may be made for employees with disabilities. Fresenius Medical Care maintains a drug-free workplace and is an equal opportunity employer.

Requirements

Associate degree or equivalent experience required.
Two to four years of related experience, or equivalent directly related work experience.
Familiarity with FDA Guidelines, ISO/AAMI/USP standards, and Design Control Concepts.
Ability to read and interpret safety rules, operating and maintenance instructions, procedure manuals, and other written, oral, diagram, or schedule instructions.
Ability to solve practical problems and handle concrete variables where standardization is limited.
Ability to perform arithmetic using whole numbers, fractions, and decimals; compute rates, ratios, and percentages; and draw and interpret bar graphs.
Strong PC skills and proficiency with Microsoft Office applications.
Strong oral and written communication skills.
Ability to meet the described physical and work-environment demands, including occasional lifting or moving of up to 50 pounds and use of required personal protective equipment.

Nice To Haves

Bachelor's degree is strongly desired.
Experience with design-control and change-control processes is preferred.
Experience with common electronic systems such as Windchill and Polarion is preferred.
Hepatitis B vaccination is strongly recommended.

Responsibilities

Write simple reports discussing results, which may include graphs and charts.
Assist senior-level staff in developing techniques and test methods and in validating test methods or test systems.
Assist in writing documents as necessary.
Assist with projects assigned by the lead technician or supervisor.
Set up, adjust, and operate equipment and instruments.
Perform experiments for development research projects under limited guidance and supervision.
Test manufactured-product samples to verify conformity to specifications.
Record test results on standardized forms and maintain good documentation practices.
Maintain laboratory and warehousing order and cleanliness, including inventories of developmental materials.
Apply company policies and procedures and build productive working relationships.
Refer complex problems to senior staff and escalate issues to a supervisor or manager as necessary.
Comply with the Code of Business Conduct, company policies and procedures, and applicable laws and regulations.
Maintain regular attendance and a good attendance record.
Maintain a laboratory notebook in accordance with standard procedures and cGMP.
Maintain general housekeeping of the work area and plant.
Perform other duties as assigned; additional responsibilities may focus on particular departments or locations.
Support creation and maintenance of phase-gate documentation for the product family.
Support creation and maintenance of product documentation, including component and material specifications, bills of materials, process and testing procedures, work instructions, and batch records.
Support creation and maintenance of the Design History File and/or dossier.
Support migration of legacy documentation into electronic format using global systems such as gPDM and Polarion.
Follow applicable Design Control and Pharmaceutical Development processes.
Assist with requirements management, including traceability between input levels, verification testing, and risk-control IDs.
Submit product documents to the electronic documentation system.
Submit change requests and change control into the electronic system.
Deliver timely and accurate compliant documentation, maintain organized Design History Files, and support design-development procedures and documents.