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). Development work may involve testing the chemical, biological, and physical characteristics or composition of solid, liquid, or gaseous 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, working under limited guidance and supervision of an immediate supervisor or lead technician. For the VS Bloodlines and Concentrates addendum, the role supports creation and maintenance of product-family phase-gate and product documentation, Design History Files and/or dossiers, and migration of legacy documentation into electronic systems. The technician follows applicable design-control and pharmaceutical-development processes and supports requirements management, document submissions, and change-control submissions. Critical deliverables include timely, accurate, and compliant documentation, and organized, maintained Design History Files. The role requires maintaining laboratory notebooks in accordance with standard procedures and cGMP, maintaining laboratory and work-area housekeeping, following company policies and applicable laws and regulations, and attending work regularly. The work may involve potentially hazardous materials and solutions, and may require occasional travel. Hepatitis B vaccination is strongly recommended.

Requirements

Associate degree or equivalent experience required.
2–4 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, and procedure manuals.
Ability to interpret written, oral, diagrammatic, or schedule-based instructions.
Ability to solve practical problems and handle varied situations with limited standardization.
Ability to perform arithmetic using whole numbers, common 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 perform the described physical duties, including occasionally lifting or moving up to 50 pounds and wearing required personal protective equipment.
Ability to work with potentially hazardous materials and solutions; work may involve experiments using human or bovine blood, plasma, or serum.

Nice To Haves

Bachelor’s degree strongly desired.
Experience with design-control and change-control processes preferred.
Experience with common electronic systems such as Windchill and Polarion preferred.

Responsibilities

May write simple reports discussing results, including graphs and charts.
May assist senior-level staff in developing techniques and test methods and performing validations on test methods or test systems.
May assist in writing documents as needed.
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, build productive working relationships, refer complex problems to senior staff, and escalate issues to a supervisor or manager as necessary.
Review and comply with the Code of Business Conduct, company policies and procedures, and applicable local, state, and federal laws and regulations.
Maintain regular attendance and a good attendance record.
Maintain laboratory notebooks in accordance with standard procedures and cGMP, and maintain general housekeeping of the work area and plant.
Perform other duties as assigned; responsibilities may focus on one or more 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 Design History Files and/or dossiers.
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 higher- and lower-level inputs, verification testing, and risk-control IDs.
Submit product documents to the electronic documentation system.
Submit change requests and change control into the electronic system.