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Title |
Location |
Type |
Rate |
Apply Now |
|
Process Engineer, Cellulose Manufacturing |
West
Chester PA |
Perm/Full |
$65,000 -
$80,000 + Bonus |
Submit Resume |
Process Engineer, Cellulose Manufacturing
OVERALL RESPONSIBILITIES:
Provide Engineering Leadership and Support for
the Launch and Maintenance of
Bacterially-Derived and/or Cellulose-Based
Biomaterials.
Design and conduct process development studies
to troubleshoot problems, introduce new
equipment and manufacturing lines, process
scale-up, and new product introduction.
Generate required documentation (Validation
Protocols, SOPs, Device Master Records,
Maintenance/Calibration Procedures) to
manufacture new products, use new procedures or
introduce new equipment to the manufacturing
operation.
Responsible for the identification,
procurement, installation, and validation of
process related equipment.
Responsible for validating new processes or
new product manufacturing procedures.
Implement Just-In-Time (JIT) or Lean
Manufacturing Principles to Cleanroom
Manufacturing Operations.
Other Duties as Assigned.
POSITION DUTIES & RESPONSIBILITIES:
Engineering Responsibility for projects
related to New Product Introduction of
Biomaterials.
Periodically evaluate production operations
for potential improvements in quality,
efficiency, and cost reductions. Insure products
are manufactured in accordance with specified
requirements.
Train manufacturing personnel in changes
implemented to manufacturing operations.
Provide technical assistance to Quality
Assurance and Regulatory Compliance personnel in
regards to new products, processes, and
procedures.
Provides other project or product support as
needed in order to support Biomaterials
business demands.
Know and follow all laws and policies that
apply to one's job, and maintain the highest
levels of professionalism, ethics and compliance
at all times.
Diligently participate in our compliance
program-related activities as denoted by your
supervisor or our Chief Compliance Officer.
PROFESSIONAL EXPERIENCE REQUIREMENTS:
3-7 years experience in a GMP manufacturing
environment (preferably cleanroom experience,
Class 100,000 or better) supporting new product
introductions and troubleshooting problems for
existing products.
Experience with fermentation, cell culturing,
media preparation and associated processing
desired.
Experience in the design, validation and
startup of small-scale biotech or similar
manufacturing processes.
Proactive approach to tasks and sense of
urgency for their completion
Ability to work effectively within a team
environment to resolve problems and implement
change
Ability to meet deadlines and multitask in a
fast paced environment
Experience with small to medium scale medical
device packaging, including conducting of
packaging and equipment validations, package
inspections, etc...
Knowledge of validation fundamentals (IQ/OQ/PQ,
etc...), statistics and process capability (CpK,
etc
)
Familiarity with Office applications (Word,
Excel, PowerPoint)
Organizational Skills, Data Management,
Effective Communication, High Attention to
Detail & Accuracy.
EDUCATIONAL REQUIREMENTS:
Bachelor of Science in Chemical, Ceramic,
Biomedical, or Industrial Engineering Preferred;
Degrees in Chemistry, Material Science,
Engineering Science or Mechanical Engineering
may be considered.
OTHER REQUIREMENTS:
Familiarity with Statistical Software
(Minitab, Statgraphics, or equivalent)
Familiarity with 2D or 3D Drafting Software
(Pro-Engineer, AutoCAD, etc
) |
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