Job Title:   Engineer, Mechanical - Biopharma (JP9751)
Location: Thousand Oaks, CA.
Employment Type:  Contract
Business Unit: Commercial Platforms, Methods and Automation
Duration: 18+ months (with likely extensions and/or conversion to permanent)
Posting Date: 1/31/2022
Notes:

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

Job Description:
Ideal candidate- MS in mechanical Engineering, 1-2 years of professional work experience, solid works, technical writing skills, Statistical skills, great problem solving skills. This is an entry level role.

Job description
The Engineer will work under the team: Mechanical Engineering Methods. They will be 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 will have the ability to work on projects that may involve changes or new product, processes, tooling, or equipment introduction to improve quality, 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.

Why is the Position Open?
Backfill.

Top Must Have Skills:

• Solid works program / CA software very preferred.
• Technical writing and project management experience a must.
• Validation/ equipment validation a plus.
• Experiment completion.
• Must be able to complete technical reports and writing.

Day to Day Responsibilities:

• Develop, qualify, and validate GMP physical test methods for vials, prefilled syringes, and injection devices.
• Provide support of senior staff for investigations as well as new process development required to improve manufacturing operations.
• Coordinate test method development and delivery with selected contractors and vendors.
• Ensure that qualification parameters are met for product requirements.
• Generate procedures necessary to support department and new process equipment.
• Maintains integrated timelines capturing appropriate cross functional details and deliverables which are aligned with the functional and project goals
• Participate in and assume responsibilities of team functions as assigned – i.e. subject matter experts for test equipment
• Generate/author and own the Test Method documents: Procedures, engineering drawings, specifications, protocols, reports, etc.
• 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
• Communicate and collaborate internally to ensure alignment, commitment to project objectives and timelines as well as to ensure effective execution of projects
• Network with manufacturing, quality and regulatory organizations both internal and external to client
• Excellent verbal and written communication skills are utilized to communicate project status and risks associated with integrated timelines to leadership

Basic Qualifications:
Master's Degree
Or Bachelor's Degree and 2 years of engineering/scientific experience (internships are considered)

Employee Value Proposition:
Career growth and opportunity.

Red Flags:

• Poor resume design
• Experience limited to CAD work
• No professional experience

Interview process:
Video Skype Panel Interview

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.