R&D Laboratory Technician II

PURPOSE AND SCOPE

Research and Development (R&D) Technician II will assist in the development of innovative products for patients with End Stage Renal Disease (ESRD). Development activities may consist of tests that determine chemical, biological and physical characteristics or composition of solid, liquid, or gaseous materials for such purposes as quality control, process control, or product development by performing the following duties. The Tech II will perform moderately complex tasks for the purpose of improving existing products and developing new products and processes.

PRINCIPAL DUTIES AND RESPONSIBILITIES

• May write simple reports discussing results, which can include graphs and charts.
• May assist senior level staff in developing new techniques, test methods (TMs) and performing validations on TMs or test systems.
• May assist in writing various types of documents as deemed necessary.
• Assist in various projects as assigned by lead technician/supervisor.
• Set-up, adjust, and operate various types of equipment and instruments.
• Perform experiments for development research projects under limited guidance and supervision of immediate supervisor/lead technician.
• Test samples of manufactured products to verify conformity to specifications.
• Record test results on standardized forms and maintain good documentation practices.
• Maintain order and cleanliness of laboratories and warehousing space, including inventories of developmental materials.
• Exercise professional capability to properly apply company policies and procedures.
• Build productive working relationships.
• Refer to senior level staff for assistance with complex problems that may arise.
• Escalate issues to supervisor/manager as necessary.
• Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.
• Regular attendance and maintaining a good attendance record is an essential function of the job.
• Maintain laboratory notebook in accordance with standard procedures and cGMP.
• Maintain general housekeeping of working area and plant.
• Other duties as assigned.

Additional responsibilities may include focus on one or more departments or locations.  See applicable addendum for department or location specific functions.

PHYSICAL DEMANDS AND WORKING CONDITIONS

• The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this job, the employee is frequently required to talk or hear, stand, walk and use hands to finger, handle, or feel. The employee is occasionally required to sit; reach with hands and arms. The noise level is usually moderate.
• Required to wear personal protective equipment that may include safety glasses, smock, steel-toed shoes, etc.
• Occasionally exposed to moving mechanical parts, fumes or airborne particles, toxic or caustic chemicals, and risk of electrical shock.
• Occasionally lift or move up to 50 pounds.
• The employee may also be required to perform experiments utilizing human or bovine blood, plasma, or serum.
• The employee may be required to work with potentially hazardous materials and solutions.
• Hepatitis B vaccination is strongly recommended.
• Occasional travel may be required.

EDUCATION

• Associates Degree or equivalent experience required, Bachelor's Degree strongly desired.

EXPERIENCE AND REQUIRED SKILLS

• 2 - 4 years related experience; or equivalent directly related work experience.
• Must be familiar with FDA Guidelines, standards (ISO/AAMI/USP), and Design Control Concepts.
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
• Strong PC skills with proficiency in Microsoft Office applications.
• Strong oral and written communication skills.

Addendum: VS Bloodlines and Concentrates Technician

•* Support the creation and maintenance of phase gate documentation for product family.

•* Support the creation and maintenance of product documentation for product family (e.g. component and material specifications, Bill of Materials, process and testing procedures, work instructions, batch records, etc.).

•* Support the creation and maintenance of Design History File and/or dosier.

•* Support migration of legacy documentation into electronic format using global systems (gPDM, Polarion, etc.).

•* Follow applicable Design Control and Pharmaceutical Development processes.

•* Assist with requirements management, including correct tracing between higher and lower level inputs, verification testing, and risk control IDs.

•* Submits product documents to the electronic documentation system.

•* Submits change requests and change control into the electronic system.

•* Critical deliverables include timely delivery of documents per design control and change control SOPs; accurate and compliant documents per 21 CFR 820.30, 21 CFR 210-211 and good manufacturing practice regulations; organized and maintained Design History Files; and design development procedures and documents.

Experience and required skills:

•* Experience with design control and change control processes preferred.

•* Experience with common electronic systems (Windchill, Polarion, etc.) preferred.

Fresenius Medical Care maintains a drug-free workplace in accordance with applicable federal and state laws.