3key Consulting, Inc.
Engineer Senior, Physical Test Methods, Drug Delivery Device (JP13325)
3key Consulting, Inc., Thousand Oaks, California, United States, 91362
Overview
Job Title: Engineer Senior, Validation Physical Test Methods, Combination Devices (JP13325). Location: Thousand Oaks, CA 91320. Business Unit: Physical Testing Systems Development. Employment Type: Contract. Duration: 18+ months with possible extension or conversion to FTE. Rate: $45 - $50/hour W2 with benefits. Posting Date: 10/30/2024. Notes: Monday, Wednesday, Friday (Remote); Tuesday, Thursday (On site) 8am - 5pm (flex) / 7am-4pm. 3 Key Consulting is recruiting an Engineer Senior, Validation Physical Test Methods Combination Devices for a consulting engagement with our direct client, a leading global biotechnology company.
Ideal Candidate Ideal candidate: Looking for a candidate with at least a Bachelor's degree and a lot of professional experience. Targeting at least 4 or more years of related work experience. Prefer candidates with work experience in the pharmaceutical industry, medical device industry or an industry that is highly regulated.
Responsibilities
The Senior Engineer is responsible for engineering activities required for development / qualification / validation and transfer of GMP physical test methods for combination products, devices, primary containers, and secondary packaging components, as required. This individual shall have the ability to work on multiple projects at one time that may involve either new or changed product, process, tooling or equipment introduction to improve product quality and reliability.
Assure transfer of new combination product test methods to QC or manufacturing by developing Six Sigma processes and compiling all required documentation.
Implement projects per Combination Product Operations (CPO) and company procedures to ensure projects are completed on schedule and within established budget.
Apply core engineering principles to develop physical test methods for medical device and combination product systems.
Perform data analysis to support method development, qualification, validation, and transfer.
Provide expert support in the design or redesign of tools and/or equipment required for manufacturing processes.
Provide expert support for investigations as well as new processes development required to improve manufacturing operations. Improvements may be required for a variety of reasons (quality, reliability, new product introduction, cost saving).
Coordinate gauge and equipment development and delivery with selected contractors.
Ensure that qualification parameters are met for product assembly and performance requirements.
Support development of cost estimates for new processes, gauges and equipment development used in generation of capital request documentation.
Generate procedures necessary to support department and new product equipment.
Provide expert training to individuals in the operation and maintenance of processes, gauges and equipment introduced to the manufacturing department (production operator, mechanics, process engineers).
Participate in and assume responsibilities of team functions as assigned (Product Improvement Teams). Supervise work of support staff during development and manufacture of system.
Excellent communication (written and verbal) and organizational skills.
Develop integrated timelines capturing cross functional details and deliverables aligned with functional and project deliverables.
Network with manufacturing, quality and regulatory organizations both internal and external to client.
Facilitate robust horizontal communication to ensure all functions are aware of changes in deliverables and impacts to risk.
Proactively identify issues and/or risks and develop mitigation options to resolve or escalate efficiently.
Integrates partner/vendor timelines with client timelines as appropriate.
Top Must Have Skill Sets
Engineering background (Mechanical, Biomedical, or Manufacturing)
Experience with CAD (SolidWorks preferred) & fixture or component design experience
Experience working in a regulated field (Medical devices, pharmaceutical, Aerospace, etc.)
Basic Qualifications
Doctorate Degree OR
Master's Degree and 3 years of Engineering experience OR
Bachelor's Degree and 5 years of Engineering experience OR
Associate's degree and 10 years of Engineering experience OR
High school diploma/GED and 12 years of Engineering experience.
Preferred Qualifications
M.S. or Ph. D. in Mechanical, Aerospace, Mechatronics, Chemical or Biomedical engineering
Excellent written and verbal communication skills together with demonstrated ability to work in a highly matrixed team environment
Experience with managing technical teams, including setting priorities and leveling resources
Technical writing experience
Spanish language skills preferred
Experienced with SolidWorks (or other 3D-CAD software)
Familiar with equipment and software IOQ
Experience with process characterization, scale-up, technology transfer experience, pFMEAs and dFMEAs
Experience with change controls, deviations, CAPA
Experience with combination products and device regulatory requirements
Understanding of the six sigma process, utilizing Minitab (or other statistical software packages) to solve statistical problems
Work history with cGMPs, regulatory filings and compliance issues for sterile injectable products manufactured by aseptic processing
Experience with machine controls (PLC, HMI) and vision systems
Why is the Position Open? Supplement additional workload on team
Red Flags
Job hopping (Every 6 months)
Not local (Greater LA area okay)
Gaps in experience (unaccounted)
Interview Process
Initial phone screening with manager
Panel interview with team (either video or onsite)
How to Apply Email: recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
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Ideal Candidate Ideal candidate: Looking for a candidate with at least a Bachelor's degree and a lot of professional experience. Targeting at least 4 or more years of related work experience. Prefer candidates with work experience in the pharmaceutical industry, medical device industry or an industry that is highly regulated.
Responsibilities
The Senior Engineer is responsible for engineering activities required for development / qualification / validation and transfer of GMP physical test methods for combination products, devices, primary containers, and secondary packaging components, as required. This individual shall have the ability to work on multiple projects at one time that may involve either new or changed product, process, tooling or equipment introduction to improve product quality and reliability.
Assure transfer of new combination product test methods to QC or manufacturing by developing Six Sigma processes and compiling all required documentation.
Implement projects per Combination Product Operations (CPO) and company procedures to ensure projects are completed on schedule and within established budget.
Apply core engineering principles to develop physical test methods for medical device and combination product systems.
Perform data analysis to support method development, qualification, validation, and transfer.
Provide expert support in the design or redesign of tools and/or equipment required for manufacturing processes.
Provide expert support for investigations as well as new processes development required to improve manufacturing operations. Improvements may be required for a variety of reasons (quality, reliability, new product introduction, cost saving).
Coordinate gauge and equipment development and delivery with selected contractors.
Ensure that qualification parameters are met for product assembly and performance requirements.
Support development of cost estimates for new processes, gauges and equipment development used in generation of capital request documentation.
Generate procedures necessary to support department and new product equipment.
Provide expert training to individuals in the operation and maintenance of processes, gauges and equipment introduced to the manufacturing department (production operator, mechanics, process engineers).
Participate in and assume responsibilities of team functions as assigned (Product Improvement Teams). Supervise work of support staff during development and manufacture of system.
Excellent communication (written and verbal) and organizational skills.
Develop integrated timelines capturing cross functional details and deliverables aligned with functional and project deliverables.
Network with manufacturing, quality and regulatory organizations both internal and external to client.
Facilitate robust horizontal communication to ensure all functions are aware of changes in deliverables and impacts to risk.
Proactively identify issues and/or risks and develop mitigation options to resolve or escalate efficiently.
Integrates partner/vendor timelines with client timelines as appropriate.
Top Must Have Skill Sets
Engineering background (Mechanical, Biomedical, or Manufacturing)
Experience with CAD (SolidWorks preferred) & fixture or component design experience
Experience working in a regulated field (Medical devices, pharmaceutical, Aerospace, etc.)
Basic Qualifications
Doctorate Degree OR
Master's Degree and 3 years of Engineering experience OR
Bachelor's Degree and 5 years of Engineering experience OR
Associate's degree and 10 years of Engineering experience OR
High school diploma/GED and 12 years of Engineering experience.
Preferred Qualifications
M.S. or Ph. D. in Mechanical, Aerospace, Mechatronics, Chemical or Biomedical engineering
Excellent written and verbal communication skills together with demonstrated ability to work in a highly matrixed team environment
Experience with managing technical teams, including setting priorities and leveling resources
Technical writing experience
Spanish language skills preferred
Experienced with SolidWorks (or other 3D-CAD software)
Familiar with equipment and software IOQ
Experience with process characterization, scale-up, technology transfer experience, pFMEAs and dFMEAs
Experience with change controls, deviations, CAPA
Experience with combination products and device regulatory requirements
Understanding of the six sigma process, utilizing Minitab (or other statistical software packages) to solve statistical problems
Work history with cGMPs, regulatory filings and compliance issues for sterile injectable products manufactured by aseptic processing
Experience with machine controls (PLC, HMI) and vision systems
Why is the Position Open? Supplement additional workload on team
Red Flags
Job hopping (Every 6 months)
Not local (Greater LA area okay)
Gaps in experience (unaccounted)
Interview Process
Initial phone screening with manager
Panel interview with team (either video or onsite)
How to Apply Email: recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
#J-18808-Ljbffr