Process Engineer
Company: Bachem
Location: Torrance
Posted on: January 12, 2021
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Job Description:
A process engineer is responsible for supporting and maintaining
critical and supporting equipment and instruments to ensure the
manufacturing process is continuously in operation with minimal
downtime. Concurrently, through process mapping, the process
engineer is responsible to develop process improvement projects to
create efficiency in the process. The process engineer will also be
responsible for identifying and researching background for
equipment purchases and making recommendation to management. Your
Tasks: Support the Director on capital projects for facility
remodeling and expansion Perform activities associated with the
design and qualification of the new and existing equipment used in
a manufacturing plant Lead the process development, optimization
and scale-up of lyophilization processes to cGMP and FDA-compliant
Oversee implementation, commissioning, and qualification of clean
room spaces and process equipment Ensure plans and resources
(people, facilities, supplies etc.) are efficiently utilized to
ensure uninterrupted supply of products produced Maximize the
success rate for production operations by instituting programs to
minimize human error, mechanical failure, contaminations, and
procedural error Support strategic plans for process and plant
improvements in order to increase efficiency and manage costs.
Maintain a safety first approach to process development and
manufacturing Communicate operational status regularly to senior
management and to corporate management, as required, at the
appropriate level of detail. Communications will be both written
documents, and in formal and informal oral presentations. Maintain
a high level of compliance and efficiency to drive the organization
to world-class manufacturing standards Write design qualifications
for qualifying batch processing tanks, reactors, filter dryers,
HPLCs, filtration system, lyophilizers, cold rooms, ultra-low
freezers, HVAC, compressed air, and purified water Create new
process and equipment drawings to existing processes based on
specifications and standards Update drawings and P&ID to
reflect changes to existing processes Maintains drawing files (CAD,
P&ID Diagram, PDF, and hard copies) Responsible for trouble
shooting and providing corrective action directives Troubleshoot
process equipment and ensuring that equipment works to its
specifications and appropriate capacities Create, execute
validation protocols and write validation summary reports Draft of
new procedures, SOP's and protocols as well as training of staff
for these expectations Perform process development studies for new
and existing projects Write summary reports to support the process
development data Write standard operations procedures, standard
test procedures, master batch records and other related GMP
documents Required: BS degree in Mechanical, Electrical, Chemical,
Manufacturing Engineering or a Science related field 3 years of
experience in engineering within a pharmaceutical manufacturing
operation Specific knowledge of cGMP, pharmaceutical manufacturing
methods and engineering principles Understanding of engineering
fundamentals Technical knowledge of processes/equipment/utilities
(e.g. batches processing, tank, filtration, lyophilization,
purified water system, HVAC, etc.) Equipment Qualification and
Validation IQ/OQ/PQ, SOPs Excellent written and oral communication
skills Ability to communicate in a proactive and solutions-focused
manner, including keeping management aware of potential issues
Ability to work independently and manage one's time Basic computer
knowledge, including Microsoft Word and Excel (used daily)
Communicate effectively and ability to function well in a team
environment Ability to effectively organize, multitask, and work in
a fast-paced, deadline driven work environment Detail oriented with
the ability to troubleshoot and resolve equipment problems. Strong
analytical math and problem solving skills Proficient in reading
schematics and diagrams as well as other written materials High
level of safety awareness Nearest Major Market: Los Angeles
Keywords: Bachem, Torrance , Process Engineer, Engineering , Torrance, California
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