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Process Engineer
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Planet Pharma New Richmond, United StatesWill be doing validation work for the contract manufacturer · This person sits on this team as the POC for the process team. Working with the internal teams to move project forward, help with decisions that need to be made, etc. · Looking for someone with broad experience in hi ...
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Process Engineer
2 weeks ago
TalentBurst New Richmond, United StatesTitle: Process Engineer · Location: New Richmond, WI · Duration: 18 Months · Summary: · The Process Engineer will be responsible for providing drug delivery device production innovation support to project teams developing combination drug delivery devices for parenteral pharmaceu ...
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Process Engineer
5 days ago
Tailored Management New Richmond, United StatesProcess Engineer III · Job Location: New Richmond, WI · Executive Summary: · We are seeking a Process Engineer III to provide drug delivery device production innovation support. This role focuses on industrializing combination drug delivery devices for parenteral pharmaceutica ...
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Process Engineer
1 week ago
TalentBurst New Richmond, United StatesTitle: Process EngineerLocation: New Richmond, WIDuration: 18 MonthsSummary: The Process Engineer will be responsible for providing drug delivery device production innovation support to project teams developing combination drug delivery devices for parenteral pharmaceutical thera ...
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Process Engineer
2 days ago
Avispa Technology New Richmond, United StatesProcess Engineer ROCGJP A leading biotechnology company is seeking a Process Engineer. The successful candidate will be responsible for providing drug delivery device production innovation support to project teams industrializing combination drug delivery devices for parenteral p ...
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Process Engineer
1 week ago
TalentBurst New Richmond, United StatesTitle: Process Engineer · Location: New Richmond, WI · Duration: 18 Months · Summary: · The Process Engineer will be responsible for providing drug delivery device production innovation support to project teams developing combination drug delivery devices for parenteral pharmace ...
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Process Engineer
10 hours ago
Avispa Technology New Richmond, United StatesJob DescriptionProcess Engineer ROCGJP A leading biotechnology company is seeking a Process Engineer. The successful candidate will be responsible for providing drug delivery device production innovation support to project teams industrializing combination drug delivery devices f ...
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Process Engineer
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The Fountain Group New Richmond, United StatesJob Description · Job DescriptionPay - $34/HR to $63/HR · First shift Hybrid. Per the HM "Mostly remote but need to be local so they can come onsite to the CMO 75% of the time. It's not a full day onsite." · Job Description: · The Process Engineer will be responsible for providin ...
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Process Engineer
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Avispa Technology New Richmond, United StatesJob Description · Job DescriptionProcess Engineer ROCGJP · A leading biotechnology company is seeking a Process Engineer. The successful candidate will be responsible for providing drug delivery device production innovation support to project teams industrializing combination dr ...
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Process Engineer III
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TalentBurst, an Inc 5000 company New Richmond, United StatesIndustry: Medical Devices · Title: Process Engineer III · Location: New Richmond, WI (Hybrid: Onsite upto 75% of the contract duration) · Duration: 18 months (+Possibilities of extension) · *TalentBurst offers comprehensive benefits to temporary employees at a cost, they include ...
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Process Engineer #PP
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Avispa Technology New Richmond, United StatesJob Description · Process Engineer ROCGJP #PP · A leading biotechnology company is seeking a Process Engineer. The successful candidate will be responsible for providing drug delivery device production innovation support to project teams industrializing combination drug deliver ...
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Process Engineer #PP
1 week ago
Avispa Technology New Richmond, United StatesJob DescriptionProcess Engineer ROCGJP #PPA leading biotechnology company is seeking a Process Engineer. The successful candidate will be responsible for providing drug delivery device production innovation support to project teams industrializing combination drug delivery device ...
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Process Engineer III
2 days ago
The Fountain Group New Richmond, United States· Responsible for, and initiate, projects within engineering areas. Including defining critical steps and resources, and developing practical and thorough solutions to complex problems. The candidate will work with limited direction and may provide guidance to and coordinate wor ...
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Process Engineer #PP
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Avispa Technology New Richmond, United StatesJob Description · Job DescriptionProcess Engineer ROCGJP #PP · A leading biotechnology company is seeking a Process Engineer. The successful candidate will be responsible for providing drug delivery device production innovation support to project teams industrializing combination ...
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Process Engineer II/III
1 week ago
BEPC Inc. - Business Excellence Professional Consulting New Richmond, United StatesBEPC is looking for a Process Engineer II/III in the St. Paul/Minneapolis, MN area to join our fast-growing team of consultants · W2 Contract: 18 months with opportunities for extensions based on business needs and performance. · Pay Range: $ /hr., based on experience + we offer ...
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Process Engineer II/III
1 week ago
BEPC Inc. - Business Excellence Professional Consulting New Richmond, United StatesBEPC is looking for a Process Engineer II/III in the St. Paul/Minneapolis, MN area to join our fast-growing team of consultants · W2 Contract: 18 months with opportunities for extensions based on business needs and performance. · Pay Range: $ /hr., based on experience + we offer ...
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Process Engineer II/III
1 week ago
BEPC Incorporated New Richmond, United StatesBEPC is looking for a Process Engineer II/III in the St. Paul/Minneapolis, MN area to join our fast-growing team of consultants · W2 Contract: 18 months with opportunities for extensions based on business needs and performance. · Pay Range: $ /hr., based on experience + we offe ...
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Senior Manufacturing Process Engineer
4 weeks ago
JobRialto New Richmond, United StatesExecutive summary: · The Senior Process Engineer will be responsible for providing drug delivery device production innovation support to project teams developing combination drug delivery devices for parenteral pharmaceutical therapeutics at Clients location. · The candidate ha ...
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Process Engineer II/III
6 days ago
BEPC Incorporated New Richmond, United StatesBEPC is looking for a Process Engineer II/III in the St. Paul/Minneapolis, MN area to join our fast-growing team of consultants · W2 Contract: 18 months with opportunities for extensions based on business needs and performance. · Pay Range: $ /hr., based on experience + we offe ...
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Process Engineer II/III
1 week ago
BEPC Incorporated New Richmond, United StatesBEPC is looking for a Process Engineer II/III in the St. Paul/Minneapolis, MN area to join our fast-growing team of consultants · W2 Contract: 18 months with opportunities for extensions based on business needs and performance. · Pay Range: $ /hr., based on experience + we offe ...
Senior Manufacturing Process Engineer - New Richmond, United States - JobRialto
Description
Executive summary:
The Senior Process Engineer will be responsible for providing drug delivery device production innovation support to project teams developing combination drug delivery devices for parenteral pharmaceutical therapeutics at Clients location.
The candidate has in depth experience in high volume manufacturing processes and methodologies and leads process development to support clinical and commercial production activities within client's device development programs.
The Senior Process Engineer will be assigned responsibilities to engineering areas and will initiate projects, define critical steps and resources, and develop practical and thorough solutions to complex problems.
The work is reviewed with a focus on long-term perspectives, as the candidate establishes his/her own work priorities and timelines.
Job Responsibilities:
The incumbent in this position will be responsible for providing design, development, and commercialization support to project teams that are developing combination drug delivery devices for parenteral pharmaceutical therapeutics at clients location.
This objective will be accomplished by executing activities in the areas of:
Process Engineering
Provide DFM/DFA assessment of container-device, and development of testing methods to assess container and deliver system quality and functionality for existing and new technologies.
Extensive application of tools to assess design process capabilities such as tolerance analysis, design of experiments, design for reliability, quality by design, design for six sigma, failure modes effect analysis
Characterize and evaluate critical process parameters (CPPs) using appropriate tools such as DOEs, components of variance, house of quality, etc., leveraging electromechanical presses and custom fixtures to run simulations in the lab.
Characterize material attributes (MAs) using appropriate tools such as tolerance analyses, empirical / mechanistic modeling with Monte Carlo simulation, etc.
Procure lab-scale clinical manufacturing equipment. Design, fabricate, and procure fixtures for device assembly and testing.
Author / review documentation related to clinical and commercial equipment qualification activities including pFMEAs, FAT, IOQ, and PQ. Author / review process validation protocol(s) and report(s).
Author / review SOPs for clinical/ commercial manufacturing (including labeling, packaging, preventative maintenance, and equipment operation).
Provide engineering technical leadership to internal cross functional team and external development partners and component suppliers
Recommend assembly processes and techniques that provide the most cost effective, robust and reliable performance for medical devices
Quality System Compliance:
Understand, implement, and maintain Roche Pharma Quality Policy and Pharma Quality System (PQS) in the department.
Developed root cause analysis on manufacturing defects and collaborated in the completion of Engineering
Change Request (ECR), Material Review Board (MRB), and Corrective and Preventive Action (CAPA)
Use (and create and implement, if necessary) local PTDU-D procedures and templates ensuring alignment with current versions of PQS documents and best practices.
Assist with resolving issues arising from internal quality assessments/audits, regulatory inspections and notified body interactions, and aid in driving closure of inspection issues by preparing appropriate responses and corrective action resolutions.
Ensure compliance of training to PQS and job-related requirements.
Design Controls:
Responsible for transfer of design to commercialization
Ensure product quality and design requirements are traced through the equipment development, process development and validation process.
Draft, review and/or approve design control documents (i.e. DHF documents) to support device development deliverables using available templates, such as protocols and reports, failure modes effects and analysis, risk management plans, change management plans and design review meeting minutes.
Employ good document practices (GDP) when recording data, maintaining archives and drafting and reviewing documents.
Participate in hazards analysis and design assessments and reviews.
Utilize electronic document archive system and collaborate with Document Control team to ensure document compliance with PQS standards and DHF regulations.
Regularly interface with leaders in Contract Manufacturing, Procurement, Quality, Complaints and Regulatory Affairs.
Regularly interact at a detailed technical level with design engineers, equipment and production engineers.
Support supplier selection through assessment of supplier capabilities for existing equipment and custom automation development, acceptance and installation
Collaborate with internal / external teams to translate design requirements into clinical and commercial processes
Qualifications
Education and Industry Experience:
B.S, M.S, or advanced degree in Engineering, with preference for Mechanical Engineering, or the equivalent.
At least 8 years of experience in the industry and/or academia (including advanced studies) after receiving their Bachelors degree.
In depth experience in high volume manufacturing processes and methodologies, with an emphasis in plastic molding and mechanical assembly is expected.
Experience working with control systems to be used in production and batch release.
Strong expertise with statistical handling and interpretation of data, technical report writing and reviewing.
Familiarity with risk management tools; develop FMEAs of the products and ability to assess changes, non-compliances, etc., with risk assessment methods.
Strong skills in relevant modeling and design tools, design controls and/or statistical analysis
Examples may include:
At least 5 years' experience supporting process development from feasibility to New Product Introduction
Interaction with Equipment/Process:
Plastic Heat stake, Plastic Laser welding, Laser Etching, Zebra Printers, Leak tests (pressure decay), Flow test, Bubble test, drop test, Pull test, semi-automated and automated Assembly equipment, Functional Testers, Smart-scopes, Height gauges, Vision Systems
Modeling:
Monte Carlo Simulations, Tolerance Analysis, Finite Element Analysis.
Device Design:
CADD (Solidworks, AutoCad), Design for Manufacturability, Molding.
Full data and statistical analysis (JMP, Minitab) and Design of Experiments, and providing detailed review of data with an emphasis on statistics.
Design Controls for regulatory compliance & filing (ISO 13485, etc): GDP/GLP/GMP, Design History Files, User Requirement Specifications (URS), Factory/Site Acceptance Testing (FAT/SAT), test protocols, technical reports, control systems to be used in production and batch release and risk management tools (methods, FMEAs, non-compliances, etc)..
Interpersonal skills:
Proven track record of working effectively in a matrix organization with a highly cross-functional (e.g., validation, quality, and program management) and collaborative environment is very desirable.
Able to work with external design/development and production partners is also highly desirable.
Highly organized and detail oriented.
Excellent leadership skills.
Demonstrated success in project planning, resource management, and liaising with engineering and manufacturing resources in other countries
Education:
Bachelors Degree
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