Apply to Senior Engineer, Biotech Medical Device (JP10972)

Job Title: Senior Engineer, Biotech Medical Device (JP10972)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: Physical Testing Systems Development
Duration: 18+ months with likely extensions and/or conversion to permanent
Posting Date: 10/28/22

3 Key Consulting is hiring Senior Engineer 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.

Responsibilities include managing a team to:

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 the company
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 project 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

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

Top Must Have Skills:

Technical writing experience - 1-2 years
Experience with regulated industry, preferred
Experience with data analysis, preferred
BS or Masters Degree with a minimun of 3-4 years of experience

Red Flags:
No formal engineering training
No BS degree
Job jumping - multiple job changes within the year

Interview process:
Phone, then in Person/Webex panel

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.