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Title |
Location |
Type |
Rate |
Apply Now |
|
Process Engineer, Biomaterials Admin. |
West
Chester PA |
Perm/Full |
$65,000 -
$80,000 + Bonus |
Submit Resume |
Process Engineer, Biomaterials Admin.
Provide Engineering Leadership and Project
Management for the Development and Launch of
Biomaterial Implants of a Ceramic, Polymeric,
and Metallic Nature.
Implement Just-In-Time (JIT) or Lean
Manufacturing Principles to Cleanroom
Manufacturing Operations.
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.
Other Duties as Assigned.
POSITION DUTIES & RESPONSIBILITIES:
Active Project Management and Technical
Leadership 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:
5-10 years experience in a cleanroom
environment (Class 100,000 or better) supporting
new product introductions and troubleshooting
problems for existing products.
Experience with ceramic manufacturing
processes within the medical device industry
desired, (i.e bone void fillers, restoratives,
cements).
Processing experience with the Development and
Formulation of Emulsification, Molding,
Slipcasting, Gelcasting, and Ceramic
Post-Purification Processes.
Proactive approach to tasks and sense of
urgency for their completion
Project Management Experience including
familiarity with project software.
Experience in developing Just-In-Time/Lean
manufacturing processes, including forecasting,
capacity analysis, cell layout and man/machine
balances.
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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