Process Engineer
Company: Bachem
Location: Torrance
Posted on: May 12, 2022
Job Description:
The Swiss based Bachem Group is a public, innovation-driven
company specializing in the development and manufacturing of
pepTides and oligonucleoTides. As a full service provider Bachem
offers products for clinical development and commercial
applications as well as a comprehensive catalog and exclusive
custom synthesis. With 50 years of experience and subsidiaries in
Switzerland, the United States, the United Kingdom and Japan,
Bachem is the partner of choice for the biotech and pharma industry
worldwide.Bachem. Leading Partner in TidesIn order to continue our
organic growth, we are constantly looking for talent.Your
ResponsibilitiesA 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 documentsYour Profile
- 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 awarenessCandidates for positions as US
employees of Bachem Americas, Inc. ("Company") must be in the
process of or fully vaccinated against the COVID-19 virus and
provide the Company with proof of vaccination as a condition of
employment, except for U.S. employees who request and qualify under
applicable law for disability and religious accommodation from the
COVID-19 vaccine mandate. An applicant who receives an offer of
employment from the Company for a position as a U.S employee will
be required to provide proof of vaccination status, or request and
receive a disability or religious accommodation for which the
applicant is entitled under applicable law, before their first day
of employment or any later deadline specified by the Company in the
offer letter. The Company is an equal opportunity employer and
provides employment opportunities and makes employment decisions
without regard to an individual's disability, religion or on any
other basis prohibited by law.
Keywords: Bachem, Torrance , Process Engineer, Other , Torrance, California
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