Position: Laboratory Technician II-LV Fill/ Freeze Drying

Reports to: Production Supervisor(s)

Department: Production
Date Revised: May 2014
FLSA Status: Non-Exempt (hourly)

Summary:
The Laboratory Technician in the LV Fill/Freeze Drying Production department performs general
laboratory functions which include, but are not limited to the following tasks: batching and filling of
vaccines; monitoring and unloading freeze dryers; preparation for and clean up after all production
operations; and washing, wrapping and sterilizing glassware and equipment. The incumbent will be
proficient in the Live Fill/Freeze Drying department and require minimal supervision in that area.
Competencies:
Accurately records data and information regarding equipment function or production parameters
to support production processes, including production records, room/temp records and chart
recorders.
Consistently strives to produce appropriate volume of work with high quality results.
Understands, practices, and trains new technicians on the importance of good aseptic technique
and biosecurity measures.
Assists with training of new technicians, confirming that they have been properly trained on the
procedure at hand and all required training documentation has been completed. Understands
and can effectively communicate the necessity for, and the effects of, each task performed.
Performs duties according to established Standard Operating Procedures (SOP's) and company
safety procedures. Assists with maintaining SOPs; uses proper change control procedures when
drafting or recommending updates. Cross checks SOPs against manufacturing documents to
ensure they not in conflict with one another and alerts Team Leader and/or Production
Supervisor immediately if a discrepancy is found.
Able to perform tasks with little guidance in several sections. Understands and accurately
performs all aspects of at least one specific section from prep work to finalized paperwork
independently.
Performs all duties, processes, protocols and paperwork with persistent focus on quality and
safety. Supports a culture of quality by encouraging co-workers to be diligent in the
performance of each task, continually striving for accuracy and improvement.
Accepts and receives constructive criticism as motivation to always perform at a higher level. All
employees must be willing to share ideas. Must be open and willing to verify a co-workers work
and be willing to have own work checked for accuracy.

Duties:
Virus (live and killed) production, including assistance with room and equipment preparation,
setup, prepping and cooking vials, mixing, sampling, filling and clean up.
Setup, load, unload and operate fill machines (manual and automatic), including shelf loading,
starting cycles, ending cycles, storage settings, cleaning, and troubleshooting alarms using
synoptic function. Performs initial troubleshooting and problem solving.
Breakdown, cleaning and setup of automated fill machine and various parts, including optics,
J ob Description
guide bars, plates, rails, and foot pegs, based on vial sizes.
Demonstrates understanding of freeze drying processes and theories. Analyzes patterns of runs
to identify and correct potential problems.
Operation of Batching Tank cycles, including Clean In Place (CIP) and Steam In Place (SIP)
processes.
Clean up and Prep work -includes, but is not limited to, the following: washing, wrapping and
sterilizing of glassware and laboratory equipment; loading/unloading autoclaves; washing
ceilings, walls, floors, furniture, fixtures and equipment; wrapping and traying of live virus vials.
Review, finalize and ensure that the production paperwork packet for LV Fill/Freeze Drying
department is accurate and thorough. Completes all necessary documentation for fills legibly and
concurrently.
May be asked to assist in reviewing and revising SOPs to ensure that the procedure is
continuously aligned to the SOP.
May be asked to serve as a Peer Mentor to new employees.
Evening, early morning and weekend work will be required. Should live within 30 minutes of the
Winslow site.
Performs other duties as assigned.
Additional Duties may include:
Egg handling, which may include receiving, traying, candling, and disposal.
Virus (killed) production, including assistance with room and equipment preparation, setup,
inoculation, harvest, antigen processing, filling and clean up.
Bacteriology assists in preparation of media and growth, harvest, processing, and inactivation
of antigen.
Tissue culture assists in preparation of lab, kitchen work, dispensing, and harvesting of antigen.
Emulsion assist in the preparation, cleaning, mixing, emulsifying of killed antigen formulations

Qualifications:

Associate's or Bachelor's degree preferred. In lieu of a post-secondary education, a High School Diploma
with a minimum of one year of relevant experience with excellent aseptic technique, a quality minded
approach, demonstrated initiative and a proven commitment to continuous improvement.

Sharp attention to detail and a strong ability to organize and prioritize work flow in order to meet
deadlines are essential. The incumbent must be capable of problem solving independently. Must have a
strong work ethic, be flexible and demonstrate a willingness to adapt. Must have mechanical skills and
the initiative to troubleshoot and resolve mechanical issues. Must have experience working with
computers and be proficient in Microsoft Office, including Word and Excel. Must be an effective member
of a team and be able to follow written and oral instructions. Must possess proven math skills as well as
oral and written communication. Must exhibit patience and a resilient positive attitude.

Note: All LAHI job descriptions are guidelines to assist employees in awareness of qualifications and performance
expectations for their respective positions. It is not possible or desirable to commit every detailed aspect of each job
to a written description. Each employee is expected to continually improve their knowledge and understanding of
their job requirements and to use this information to increase insight as to the scope of their responsibilities. J ob
descriptions alone cannot be used as an argument to refuse work assignments.



Incumbent Signature Date