Process Engineer I
Company: ICONMA, LLC
Location: Salt Lake City
Posted on: May 27, 2023
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Job Description:
This position is responsible for performing activities related
to critical aspects of products and processes, including process
development, pre-validation and optimization of solid oral dosage
forms after Abbreviated New Drug Application (ANDA) filing
throughout product launch and commercial lifecycle.
Executes studies with Research and Development (R & D), Laboratory
Technical Services (LTS), manufacturing and planning.
Maintains expertise related to formulation, raw material properties
and manufacturing processes.
Identifies, analyzes and suggests corrective actions to optimize
procedures, processes, materials, technology and regulatory
compliance issues. Provides direction and training to other staff,
technicians and manufacturing operators.
Adapting Operational Excellence (OpEx) initiatives to improve
throughput, reduce waste, improve safety of the existing commercial
products. Coordinate manufacturing of additional batches if
required and prepare technical reports.
Performing process validation activities including process design,
process qualification, continuous process verification reviews
(CPV), statistical assessments and trend analysis and cleaning
validation for the commercial and new products.
Performing investigations to identify the root causes and actively
seek remediation approaches and implement Corrective and Preventive
Actions (CAPAs)
Provide Technical assessments/ product impact assessment summaries
on time.
Evaluate the material changes such as changes to the manufacturing
process of Active Pharmaceutical Ingredient (API) or site
manufacturing changes for raw materials (API, excipients) and
packaging components. Coordinate the manufacturing activities and
prepare technical reports.
Execute the experimental and process confirmation studies.
Supports pre-validation commercial scale report that includes
detailed summary of the equipment and qualified equipment
parameters (QEPs) assessment, CPPs and CQAs identified during
pre-validation work.
Participation in internal (Corporate and QA audits) and external
(FDA, MHRA) audits.
Leading multiple new product introductions and site transfer
projects.
Responsible for performing additional related duties as
assigned.
Requirements
Requires a Master's degree in chemistry OR chemical engineering OR
Pharmaceutical Science with a 1-3-year relevant experience in the
field of Pharmaceutical manufacturing and/or pharmaceutical
formulation and/or pharmaceutical process development and
pre-validation OR related field.
Some knowledge of CGMP, FDA, Occupational Safety and Health
Administration (OSHA), Environmental Protection Agency (EPA), DEA
and other regulatory requirements.
Intermediate statistical computations (Cpp, Cpk, Regression
analysis, etc.) and use of statistical software (JMP, Minitab,
Statease etc.).
As an equal opportunity employer, ICONMA prides itself on creating
an employment environment that supports and encourages the
abilities of all persons regardless of race, color, gender, age,
sexual orientation, citizenship, or disability
Esther Padi
Phone: (248) 406-1579
Keywords: ICONMA, LLC, Salt Lake City , Process Engineer I, Engineering , Salt Lake City, Utah
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