Process Engineer I

Company: ICONMA, LLC
Location: Salt Lake City
Posted on: May 27, 2023

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