Apply to Engineer, GMP Test Methods Medical Device – (JP11088)

Job Title: Engineer, GMP Test Methods Medical Device – (JP10960 / 11088)
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: 11/28/2022
Notes: HYBRID - NEEDS TO BE LOCAL TO USTO to come onsite a few days a week

3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
The Engineer, in Manufacturing Science and Technology, is responsible for engineering activities required for the development / qualification / validation and transfer of physical GMP test methods for combination products, devices, primary containers, and secondary packaging components. The Engineer shall have the ability to work on multiple projects at one time that may involve changes or new product, processes, tooling, or equipment introduction to improve quality and reliability and reduce cost. Phases of projects include: developing combination product test methods, providing key expert support for qualification, validation, transfer, and life cycle support of methods for manufacturing, new product introduction, training, and production support.

Top Must Have Skills:

Experience in technical testing and CAD and/or Solidworks design.
Excellent written and verbal communication.
Work as an individual and a team member

Day to Day Responsibilities:

Develop, qualify, and validate GMP physical test methods for vials, prefilled syringes, and injection devices.
Work in teams to transfer new combination product test method and assembly requirements to manufacturing, by developing six sigma processes and compiling documentation for manufacturing assembly requirements.
Develop, qualify, validate, and transfer new equipment, software, systems, and methods.
Implement projects per MSAT and company procedures to ensure projects are completed on schedule and within established budget.
Provide expert support for investigations as well as new process development required to improve manufacturing operations.
Coordinate test method development and delivery with selected contractors.
Ensure that qualification parameters are met for product assembly 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 process equipment.
Provide expert training to individuals in the operation and maintenance of processes, test methods and equipment introduced to Quality Control and/or 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).
Generate/author and own the Test Method documents.
Gather test method requirements that result in equipment that operates safely and considers ergonomic factors in the design
Perform other duties as required by the Group Manager
Comply with the requirements, responsibilities, and authority as required
Maintains integrated timelines capturing appropriate cross functional details and deliverables which are aligned with the functional and project goals
Networks internally to ensure alignment, commitment to project objectives and timelines as well as to ensure effective execution of projects
Networks with manufacturing, quality and regulatory organizations both internal and external to the client
Drives the cross-functional communication and integration of information to optimize decision making, issue resolution and change management throughout project lifecycle
Excellent verbal and written communication skills are utilized to communicate project status and risks associated with integrated timelines to leadership
Collaborates with other functional leaders to ensure project success, momentum and commitment
Proactively identifies issues and/or risks and develops mitigation options to resolve or escalate efficiently
Integrates partner/vendor timelines with company timelines as appropriate

Employee Value Proposition:
Career growth, opportunity

Red Flags:

No previous experiences.
Gaps more than 6 months in the resume.
Frequent job changes.
No technical degree.

Interview process:
Starts with one-to-one phone call. (30 min)
Then the interview with the panel. (1 hour)
Lastly, if possible, an in person meeting on site. (1 hour)

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.