Engineer Senior, Validation Physical Test Methods Combination Devices - Hybrid (JP12037)

Job Title:  Engineer Senior, Validation Physical Test Methods Combination Devices - Hybrid (JP12037)
Location: Thousand Oaks, CA.  91320
Business Unit: Physical Testing Systems Development
Employment Type:  Contract
Duration: 6+ monthss (with possible extensions)
Rate: $46 - $51/hour W2
Posting Date: 12/18/2023
Notes: Only qualified candidates need apply.  Hybrid – Must be local to Thousand Oaks, CA. as follows:
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.
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 Skill Sets:

• Experience performing data analysis using statistical software, (JMP, Minitab)
• Experience modeling test fixtures, reference samples on solidworks or any other CAD software
• Root cause analysis, CAPA deviation
• Equipment method and test validation experience
• Technical writing experience

Day to Day 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
• OAssociate'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:

• No engineering background.
• No CAD background.
• No troubleshooting and root cause investigation experience.
• No data analysis experience.
• No technical writing experience
• Lack of experience working in technical team / team work

Interview Process:

• 1st initial phone screen
• 2nd interview in person panel

We invite qualified candidates to send your resume to resumes@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.