Engineer Senior - Calsoft Labs
Thousand Oaks, CA 91320
About the Job
Hybrid - MUST BE LOCAL TO USTO and able to report onsite every week.
Copy of AMAGJP00012037 - please no formally shortlisted/ rejected job seekers
Monday, Wednesday, Friday (Remote)
Tuesday, Thursday (On site) 9am - 5pm (flex) / 7am- 4pm
EM FEEDBACK- Looking for a candidate who has not job hopped every 6-8 months and has a solid root cause analysis skills, technical writing, statistical background, CAD skills, thinker, problem solver, etc
Mainly Mechanical, Manufacturing, Biomedical engineers. Coding skills is a plus but not required. Candidates experience with Instron (or any other Force Tester), Keyence is a huge plus. Not so much candidates with QA/QE background they are usually good with documents and statistics and not so much a problem solver or overall technical.
Hiring Manager Feedback with regards to education and experience level preference for 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 to see candidates with work experience in the pharmaceutical industry, medical device industry or an industry that is highly regulated.
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Job Summary
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 container, 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.
RESPONSIBILITIES:
" 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 (i.e. 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 (i.e. production operator, mechanics, process engineers).
" Participate in and assume responsibilities of team functions as assigned (i.e. Product Improvement Teams). Supervise work of support staff during development and manufacture of system.
" Excellent communication (written and verbal) and organizational skills
" Develops and maintains integrated timelines capturing appropriate cross functional details and deliverables which are aligned with the functional and project deliverables
" Networks with manufacturing, quality and regulatory organizations both internal and external to Client
" Facilitates robust horizontal communication to ensure all functions are aware of changes in deliverables and impacts to risk.
" Proactively identifies issues and/or risks and develops mitigation options to resolve or escalate efficiently
" Integrates partner/vendor timelines with Client timelines as appropriate
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
Copy of AMAGJP00012037 - please no formally shortlisted/ rejected job seekers
Monday, Wednesday, Friday (Remote)
Tuesday, Thursday (On site) 9am - 5pm (flex) / 7am- 4pm
EM FEEDBACK- Looking for a candidate who has not job hopped every 6-8 months and has a solid root cause analysis skills, technical writing, statistical background, CAD skills, thinker, problem solver, etc
Mainly Mechanical, Manufacturing, Biomedical engineers. Coding skills is a plus but not required. Candidates experience with Instron (or any other Force Tester), Keyence is a huge plus. Not so much candidates with QA/QE background they are usually good with documents and statistics and not so much a problem solver or overall technical.
Hiring Manager Feedback with regards to education and experience level preference for 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 to see candidates with work experience in the pharmaceutical industry, medical device industry or an industry that is highly regulated.
------
Job Summary
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 container, 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.
RESPONSIBILITIES:
" 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 (i.e. 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 (i.e. production operator, mechanics, process engineers).
" Participate in and assume responsibilities of team functions as assigned (i.e. Product Improvement Teams). Supervise work of support staff during development and manufacture of system.
" Excellent communication (written and verbal) and organizational skills
" Develops and maintains integrated timelines capturing appropriate cross functional details and deliverables which are aligned with the functional and project deliverables
" Networks with manufacturing, quality and regulatory organizations both internal and external to Client
" Facilitates robust horizontal communication to ensure all functions are aware of changes in deliverables and impacts to risk.
" Proactively identifies issues and/or risks and develops mitigation options to resolve or escalate efficiently
" Integrates partner/vendor timelines with Client timelines as appropriate
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
Source : Calsoft Labs
