208 Engineer Senior, Biotechnology - (JP11094) Jobs in Thousand Oaks, CA
SORT BY
3
3
3
3
R
R
J
B
A
B
A
A
3
3
3
3
3
3
3
3
3
3
3
3
3
Engineer Senior, Biotechnology - (JP11094)
$98k-119k (estimate)
Full Time | Business Services
5 Months Ago
3 Key Consulting is Hiring an Engineer Senior, Biotechnology - (JP11094) Near Thousand Oaks, CA
Job Title: Engineer Senior, Biotechnology - (JP11094)Location: Thousand Oaks, CA.Employment Type: ContractBusiness Unit: Physical Testing Systems DevelopmentDuration: 18 months (with likely extensions and/or conversion to permanent)Posting Date: 11/22/22Notes: Only qualified candidates need apply. 100% onsite. Monday - Friday 8am - 5pm (flex)/ 7- 4pm.3 Key Consulting is hiring an Engineer Senior for a consulting engagement with our direct client, a leading global biopharmaceutical company.Job Description: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.Top Must Have Skills:
- Technical writing experience - 1-2 years
- Experience with regulated industry, perferred
- Experience with data analysis, peferred
- BS or Masters Degree with a minimun of 3-4 years of experience
- 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
- 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.
- 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
- 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
- No formal engineering training
- Job Jumping - multiple job changes in a year
- 1 Phone
- 2 In Person/webex panel
Job Summary
JOB TYPE
Full Time
INDUSTRY
Business Services
SALARY
$98k-119k (estimate)
POST DATE
12/13/2023
EXPIRATION DATE
06/01/2024
WEBSITE
3keyconsulting.com
HEADQUARTERS
WEST HILLS, CA
SIZE
100 - 200
FOUNDED
2009
TYPE
Private
REVENUE
$50M - $200M
INDUSTRY
Business Services
Related Companies
Show more
Similar Jobs
Popular Articles
Top 10 Things to Avoid Putting on a Job Application
Read Article
How to Describe Your Education in a Resume
Read Article
How to Write a Memorable Cover Letter in 5 Ways
Read Article
4 Personal Finance Tips to Make During Job Transition
Read Article
4 Best Camera Setups for Interview
Read Article
Keeping a Job Search Journal: 9 Types of Journaling You Can Do
Read Article
