What are the responsibilities and job description for the Process Engineer position at ICONMA, LLC?
Candidates must have the following skills listed on the resume to be considered for the role:
Core essential things:
Minimum 2 to 5 years experience in Pharmaceutical Formulation and/ or Process development of Oral solid dosage forms.
Experience with Wet granulation, Dry granulation, tablet compression, capsule filling and hands on exposure to equipment such as High Shear granulators, blenders, hot melt extruders, extrusion/spheronization, compression equipment, encapsulators, tablet pan coaters etc.
Experience in process validation and equipment validation is a plus.
Position Summary
This position is responsible for performing activities related to critical aspects of products and processes, including process development, prevalidation and optimization of solid oral dosage forms after Abbreviated New Drug Application (ANDA) filing throughout product launch and commercial lifecycle including validation. Executes studies with Research and Development (R & D), Laboratory Technical Services (LTS), manufacturing and planning. Maintains of 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.
Essential areas of responsibility:
All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary.
Any nonessential functions are assumed to be included in other related duties or assignments.
Act as Subject Matter Expert (SME) for new product launches and commercial products on site.
Point of contact for providing support for the other departments.
Critical thinking and independently driving projects to completion.
Providing process engineering expertise for technology transfer, from pre validation through commercial lifecycle for modified release solid oral dosage form manufacturing including scale up, validation and lifecycle changes.
Perform technical analysis to understand and reduce technology transfer risk, estimate cycle time, improve equipment fit, and implement required technologies.
Provide continued technical leadership to commercial operations and ensure cost effective and robust manufacturing processes for various unit operations including blending, sizing, compression, coating, fluid bed processing, and Client technologies.
Contributing to business teams through innovation, strategic input, and industry knowledge to trouble shoot and achieve cost leadership.
In accordance with the Americans with Disabilities Act, it is possible that requirements may be modified to reasonably accommodate disabled
individuals.
However, no accommodations will be made which may pose serious health or safety risks to the employee or others or which impose an undue hardship on the Company.
The incumbent is responsible to ensure compliance with all laws, regulations, codes, standards and company policies relevant to this position.
This document in no way states or implies that only the duties described above are to be performed by the incumbent.
The incumbent will be expected to follow instructions and perform duties as required by his or her supervisor and understand that aspects of their position may be changed by the Company on an as needed basis.
Perform engineering analysis of process execution, recommends opportunities for improvement with plant efficiency and risk mitigation as goals, and captures analysis in campaign summary documents.
Provide process expertise in post batch record review and analysis.
Act as a quality events investigator for assigned projects.
Lead documentation for equipment, lead FMEAs, recommend equipment modifications as needed for validation optimization, Analyze statistical data from qualification, product or functional specifications to determine conformance with standards and established quality requirements.
Maintain product during lifecycle (stage 3 – CPV) using appropriate statistical tools.
Implement and lead use of new pharmaceutical manufacturing technologies including melt extrusion, spray drying, extrusion – spheronization, spray congealing, laser drills, nano particulates, continuous manufacturing, NIR, PAT, etcetera.
Lead and execute material changes, process changes, cost reduction projects and CPV.
Responsible for completing all training requirements and maintaining 100% compliance with all assignments.
Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), and Standard Operating Procedures (SOP’s) and Batch Record instructions.
Responsible for performing additional related duties as assigned.
Position Requirements
Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.
Education/Certification/Experience:
Requires a bachelor’s degree pharmacy, engineering or science with a minimum of 10 years’ relevant experience in the field of Pharmaceutical manufacturing and/or pharmaceutical formulation and/or pharmaceutical process development and pre validation OR related field.
Advanced degree is preferred.
A combination of education and experience will be considered.
Skills/Knowledge/Abilities:
Understanding of various unit operations used in conventional and Client oral solid dosage manufacturing.
Comply with FDA regulations at all times.
Business, scientific and personal computer hardware and software applications.
Skill levels in MS Office including proficiency in Word, PowerPoint, Excel and SharePoint.
Must be able to maintain the highest levels of confidentiality, integrity and discretion.
Excellent verbal, written, and interpersonal skills required.
Problem Solving:
Proactively works on problems of a moderate to complex scope where evaluation of contributing factors requires the analysis of situations or data and an in depth knowledge and evaluation of various known and unknown factors.
The requirements and responsibilities in this position description do not create an employment contract and are not meant to be all inclusive.
The incumbent will be expected to follow instructions and perform duties as required by his or her supervisor and understand that aspects of their
Seeks out all resources when selecting methods and techniques for obtaining results.
Acts independently and proactively to recommend and administer methods and procedures for problem resolution.
Able to identify solutions to general problems through collaboration and creativity.
Physical requirements:
Frequent:
Walking to move short distances quickly and frequently.
Repetitive Motions (frequent motions of the wrists, hands and/or fingers).
Sitting for extended periods at workstation or mobile equipment.
Using fingers to perform activities such as picking, pinching or typing.
Visual Acuity:
Visual acuity to perform activities such as operating machines (i.e. lathes and drill presses) where the seeing job is at or within arm’s reach.
Close visual acuity to perform activities such as computer work, preparing and analyzing data, extensive reading, and visual inspection involving small defects, small parts and/or operation of machines (including inspection), using measurement devices and/or assembly or fabrication of parts at a distance close to the eyes.
Working environment:
Low to loud noise level exposure.
24/7 Support based on business needs.
Fast paced environment.
Able to manage multiple priorities and ensure appropriate followups.
Highly organized and excellent time and project management skills with the ability to juggle a wide range.
Ability to work under pressure and meet deadlines.
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.
Core essential things:
Minimum 2 to 5 years experience in Pharmaceutical Formulation and/ or Process development of Oral solid dosage forms.
Experience with Wet granulation, Dry granulation, tablet compression, capsule filling and hands on exposure to equipment such as High Shear granulators, blenders, hot melt extruders, extrusion/spheronization, compression equipment, encapsulators, tablet pan coaters etc.
Experience in process validation and equipment validation is a plus.
Position Summary
This position is responsible for performing activities related to critical aspects of products and processes, including process development, prevalidation and optimization of solid oral dosage forms after Abbreviated New Drug Application (ANDA) filing throughout product launch and commercial lifecycle including validation. Executes studies with Research and Development (R & D), Laboratory Technical Services (LTS), manufacturing and planning. Maintains of 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.
Essential areas of responsibility:
All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary.
Any nonessential functions are assumed to be included in other related duties or assignments.
Act as Subject Matter Expert (SME) for new product launches and commercial products on site.
Point of contact for providing support for the other departments.
Critical thinking and independently driving projects to completion.
Providing process engineering expertise for technology transfer, from pre validation through commercial lifecycle for modified release solid oral dosage form manufacturing including scale up, validation and lifecycle changes.
Perform technical analysis to understand and reduce technology transfer risk, estimate cycle time, improve equipment fit, and implement required technologies.
Provide continued technical leadership to commercial operations and ensure cost effective and robust manufacturing processes for various unit operations including blending, sizing, compression, coating, fluid bed processing, and Client technologies.
Contributing to business teams through innovation, strategic input, and industry knowledge to trouble shoot and achieve cost leadership.
In accordance with the Americans with Disabilities Act, it is possible that requirements may be modified to reasonably accommodate disabled
individuals.
However, no accommodations will be made which may pose serious health or safety risks to the employee or others or which impose an undue hardship on the Company.
The incumbent is responsible to ensure compliance with all laws, regulations, codes, standards and company policies relevant to this position.
This document in no way states or implies that only the duties described above are to be performed by the incumbent.
The incumbent will be expected to follow instructions and perform duties as required by his or her supervisor and understand that aspects of their position may be changed by the Company on an as needed basis.
Perform engineering analysis of process execution, recommends opportunities for improvement with plant efficiency and risk mitigation as goals, and captures analysis in campaign summary documents.
Provide process expertise in post batch record review and analysis.
Act as a quality events investigator for assigned projects.
Lead documentation for equipment, lead FMEAs, recommend equipment modifications as needed for validation optimization, Analyze statistical data from qualification, product or functional specifications to determine conformance with standards and established quality requirements.
Maintain product during lifecycle (stage 3 – CPV) using appropriate statistical tools.
Implement and lead use of new pharmaceutical manufacturing technologies including melt extrusion, spray drying, extrusion – spheronization, spray congealing, laser drills, nano particulates, continuous manufacturing, NIR, PAT, etcetera.
Lead and execute material changes, process changes, cost reduction projects and CPV.
Responsible for completing all training requirements and maintaining 100% compliance with all assignments.
Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), and Standard Operating Procedures (SOP’s) and Batch Record instructions.
Responsible for performing additional related duties as assigned.
Position Requirements
Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.
Education/Certification/Experience:
Requires a bachelor’s degree pharmacy, engineering or science with a minimum of 10 years’ relevant experience in the field of Pharmaceutical manufacturing and/or pharmaceutical formulation and/or pharmaceutical process development and pre validation OR related field.
Advanced degree is preferred.
A combination of education and experience will be considered.
Skills/Knowledge/Abilities:
Understanding of various unit operations used in conventional and Client oral solid dosage manufacturing.
Comply with FDA regulations at all times.
Business, scientific and personal computer hardware and software applications.
Skill levels in MS Office including proficiency in Word, PowerPoint, Excel and SharePoint.
Must be able to maintain the highest levels of confidentiality, integrity and discretion.
Excellent verbal, written, and interpersonal skills required.
Problem Solving:
Proactively works on problems of a moderate to complex scope where evaluation of contributing factors requires the analysis of situations or data and an in depth knowledge and evaluation of various known and unknown factors.
The requirements and responsibilities in this position description do not create an employment contract and are not meant to be all inclusive.
The incumbent will be expected to follow instructions and perform duties as required by his or her supervisor and understand that aspects of their
Seeks out all resources when selecting methods and techniques for obtaining results.
Acts independently and proactively to recommend and administer methods and procedures for problem resolution.
Able to identify solutions to general problems through collaboration and creativity.
Physical requirements:
Frequent:
Walking to move short distances quickly and frequently.
Repetitive Motions (frequent motions of the wrists, hands and/or fingers).
Sitting for extended periods at workstation or mobile equipment.
Using fingers to perform activities such as picking, pinching or typing.
Visual Acuity:
Visual acuity to perform activities such as operating machines (i.e. lathes and drill presses) where the seeing job is at or within arm’s reach.
Close visual acuity to perform activities such as computer work, preparing and analyzing data, extensive reading, and visual inspection involving small defects, small parts and/or operation of machines (including inspection), using measurement devices and/or assembly or fabrication of parts at a distance close to the eyes.
Working environment:
Low to loud noise level exposure.
24/7 Support based on business needs.
Fast paced environment.
Able to manage multiple priorities and ensure appropriate followups.
Highly organized and excellent time and project management skills with the ability to juggle a wide range.
Ability to work under pressure and meet deadlines.
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.
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