V2 Bio-Consulting
is looking for several entry to mid-level Manufacturing Technicians
for a BioPharma client in the Hayward/ Milpitas, San Francisco Bay Area,
CA. This opportunity is for full time hours and is expected to be 3-6
months long in duration. The hourly rate for this position is commensurate
with experience. Position will be a temp with the possibility of going
permanent. This
position will:
• Support research and development activities in the Pilot Plant.
• Interact with Process Engineering, System Design Engineering
and Formulation personnel to provide support for product development
including set-up, operation, troubleshooting and dismantling equipment
used for the preparation of drug delivery systems. This includes executing
experimental, clinical and process validation operations, including
analytical measurement and basic data analysis.
• Have technical ability to work on equipment and other special
assignments
• Assist with resolving technical issues as well as maintenance
of production equipment.
• Need to be self-motivated and be able to work with minimal
supervision and have a hands-on approach to get the job done.
• Provide support for processing and validation activities for
cGMP operations
• Follow all relevant standard operating procedures and complete
master production records in a cGMP environment.
• Complete and Review batch production records to ensure cGMP
documentation practices are followed and information entered is complete
and accurate.
• Demonstrate ability to recognize equipment malfunction and
process deviations and notifies supervisor and/or engineering group.
• Ensure a safe work environment is maintained at all times.
Bring equipment and facilities issues to the attention of the Supervisor
for resolution.
• Provide communication between shifts to ensure smooth and
efficient transition of tasks.
• Assist review existing operational and process discrepancies
in manufacturing and provide technical expertise to improve procedures.
This position
requires:
• Aseptic manufacturing experience is highly desired
• The ability and experience in classified clean room manufacturing
operations is required.
• Strong mechanical aptitude and familiarity or experience in
handling drug compounds, organic chemicals and solvents is required.
• Perform duties in accordance with Current Good Manufacturing
Practices (cGMP’s), FDA and ISO guidelines.
• The ability to work and communicate in a safety-conscious,
dynamic, project-driven team focused environment is essential.
• Demonstrated basic math skills
• The ability to follow directions effectively
• Excellent written and verbal communication skills.
V2 consultants
provide local, national and international high level services to many
successful Biotech companies. Our team of experienced Project Management,
Operations, Quality, Engineering, Start up/Commissioning and Validation
professionals specialize in providing “The Owner’s Perspective”
(“TOP”) consulting services. We provide benefits including
medical, life, 401K and potential profit sharing
opportunities.
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