Company: List Biological Laboratories, Inc.
Posted on: August 7, 2022
List Lab's mission is to "harness bacteria's potential for a
healthier world." We are a premier contract development and
manufacturing organization for bacterial derived products for early
clinical trials including live biotherapeutic products derived from
the rapidly growing microbiome field. Live biotherapeutic products,
an exciting new therapeutic, are a novel approach to disease
treatment and have significant potential to improve patient lives.
List Labs also specializes in the production of both native and
recombinant bacterial proteins and toxins used for research and
List Labs offers a dynamic and congenial company environment and
the convenience of working in the South Bay Area.
We are seeking a talented and motivated Validation/Equipment
Engineer who will be responsible for providing engineering,
validation and maintenance support to process manufacturing
equipment, facility, and utilities to ensure our manufacturing
production operations run smoothly daily.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Provides engineering, validation and maintenance support to the
process manufacturing equipment, facility, and utilities at a site;
equipment may include major processing equipment such as
bioreactors, tangential flow filtration, chromatography, filling
equipment, support systems such as incubators, freezers bio-safety
cabinets, offline bench-top instruments, or facility/utility
- Ensures new equipment is appropriately designed/qualified and
existing processes run in a compliant manner through equipment life
cycle. Help define and optimize equipment qualification
- Owns and manages changes to the process equipment to maintain
equipment in a validated state.
- Investigates any equipment or process deviations and developing
corrective actions to prevent re-occurrences. Able to provide
industry wide expertise for complex equipment and process
- Participates in all external and internal audits of the
manufacturing facilities and process equipment as SME and responds
to any observations received.
- Develops and implements equipment reliability and maintenance
strategies that are compliant, effective and cost appropriate.
- Applies knowledge of engineering principles and best practices
to ensure robust solutions.
- Independently leads or provide SME support on capital related
- Establishes equipment specifications in standard documentation
- User Requirements (URS), Functional Specification (FS) and Detail
Design Specifications (DDS).
- Works closely with operations and manufacturing sciences to
evaluate new product introductions and facility fit
- Leads to define and advance facility and equipment changes in
line with 5- and 10-year strategic plans.
- Leads evaluation of new technologies and equipment platforms
- Translates current and future processes into the facility and
equipment requirements at a manufacturing site.
- Maintain and assure compliance with the Validation Master Plan,
Calibration Program, regulatory requirements, and site
- Drafting, authorize and execute validation protocols and
support validation and technical assessments for quality.
- Prepare validation summary reports for executed protocols.
- Conduct deviation investigations, such as validation failures,
complaints and hold investigations to identify and implement the
appropriate corrective actions.
- Provides accurate budget estimates for capital equipment and
- Troubleshoot technical issues and execute corrective
- Complies with all safety regulations and current Good
Manufacturing Practices (GMPs).
- 5+ years of relevant experience and a BS in engineering
(Mechanical Engineering preferred)
- 5+ years working in validation and equipment support in the
pharmaceutical and/or biotech industry, or equivalent combination
of education and experience.
KNOWLEDGE, SKILLS AND ABILITIES
- Previous experience in biotech or pharmaceuticals industry
- IQ, OQ, PQ experience.
- Excellent technical writing skills - experienced writing and
executing effective validation plans, SOPs, risk assessments,
summary reports, and final reports.
- Demonstrates a working knowledge of process engineering system,
methods, and procedures.
- Demonstrates a working knowledge of current GMPs and safety
- Demonstrates a strong verbal, written, and interpersonal
- Proficient in Microsoft Office applications.
- Strong analytical and problem-solving skills.
PHYSICAL DEMANDSThe physical demands described here are
representative of those that must be met by an employee to
successfully perform 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 regularly required to walk;
use hands to finger, handle, or feel; reach with hands and arms,
talk, and hear. The employee is required to stand; climb or balance
and stoop, kneel, crouch. The employee must occasionally lift
and/or move up to 25 pounds. Specific vision abilities required by
this job include close vision, color vision, peripheral vision,
depth perception and ability to adjust focus. Must have ability to
handle more than one task at a time and must work at a rapid pace
while maintaining attention to detail.
WORK ENVIRONMENTThe work environment characteristics described here
are representative of those an employee encounters while performing
the essential functions of this job. This job is performed in a
temperature controlled facility without exposure to extreme hot or
cold temperatures. Generally, this job is performed in a sanitized
laboratory setting and routinely uses standard medical and research
equipment such as centrifuges, biosafety cabinets, microscopes,
incubators, pipettes and computers. While performing the duties of
this job, the employee is frequently exposed to blood, viruses,
bacteria, body fluids and other hazardous material. Employees
entering and leaving the laboratory must wear appropriate clothing
and protective equipment. The noise level in the work environment
is usually moderate.
Keywords: List Biological Laboratories, Inc., San Francisco , Validation/Equipment Engineer, Engineering , Campbell, California
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