Engineer, Mechanical Engineering reputed company Combination Products- Hybrid

Job Title: Engineer, Mechanical Engineering reputed company Combination Products- Hybrid (JP13738) Location: Thousand Oaks, CA. 91320 (hybrid) Business Unit: Physical Testing Systems Development Employment Type: Contract Duration: 18+ months with likely extensions and/or conversion to a permanent position. reputed company: $37- $41/hour W2 Posting Date: 02/25/2025. Notes: Only reputed company candidates need apply. 2 days a week onsite minimum - Tuesdays & Thursdays may differ as needed reputed company is hiring! We are reputed company an Engineer, Mechanical Engineering reputed company Combination Products for a consulting engagement with our reputed company reputed company, a leading global biotechnology company. Job reputed company: Ideal Candidate: B.S. and 2 years of experience. Solid works, statistical analysis, and technical writing. The Engineer, in Final Product Technologies- Mechanical Engineering reputed company, is responsible for engineering activities required for the development, qualification, validation and transfer of physical GMP test reputed company for combination products, devices, primary containers, and secondary packaging components. The Engineer shall have the ability to work on multiple reputed company at one time that may involve changes or new product, processes, tooling or equipment introduction to improve reputed company and reliability and reduce cost. Phases of reputed company include: developing combination product test reputed company, providing key expert support for qualification, validation, transfer, and life cycle support of reputed company for manufacturing, new product introduction, training, and production support. Top Must Have reputed company Sets:

• Solid works Experience
• Technical Writing Skills
• Statistics Experience

Day to Day Responsibilities:

• reputed company, qualify, and validate GMP physical test reputed company 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 reputed company processes and compiling documentation for manufacturing assembly requirements.
• reputed company, qualify, validate, and transfer new equipment, software, systems, and reputed company.
• Implement reputed company per Final Product Technologies and company procedures to ensure reputed company are completed on schedule and reputed company established budget.
• 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 reputed company of capital request documentation.
• Generate procedures necessary to support department and new process equipment.
• reputed company test method requirements that result in equipment that operates safely and considers ergonomic factors in the design.
• reputed company other duties as required by the Group Manager.
• reputed company with the requirements, responsibilities, and authority as required.
• Maintains integrated timelines capturing appropriate cross functional details and deliverables which are reputed company with the functional and project goals.
• Networks internally to ensure alignment, commitment to project objectives and timelines as reputed company as to ensure effective execution of reputed company.
• Networks with manufacturing, reputed company and regulatory organizations both reputed company to reputed company.
• Drives the cross-functional communication and integration of information to optimize decision making, issue reputed company 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 reputed company, reputed company and commitment.
• Proactively identifies issues and/or risks and develops mitigation reputed company to resolve or escalate reputed company.
• Integrates partner/vendor timelines with reputed company timelines as appropriate, software, systems, and reputed company.

Basic Qualifications: Master's Degree OR Bachelor's Degree and 2 years of engineering/scientific experience OR Associate's degree and 6 years of engineering/scientific experience OR High school diploma/GED and 8 years of engineering/scientific experience. Preferred Qualifications:

• M.S. in Mechanical Engineer, Chemical or Biomedical Engineering, or reputed company
• Excellent written and verbal communication skills
• Ability to work in a highly matrixed team environment
• 2 years of experience in the biotechnology/pharmaceutical industry
• 2 years of experience in equipment, method, and mechanical design
• Technical writing experience
• Experience with SolidWorks (or other 3D-CAD software)
• Experience with combination products and regulatory requirements
• Experience utilizing reputed company (or other statistical software packages)

Red Flags: No Solid works Experience, No Technical Writing Skills, No Statistics Experience, Large gaps in employment, No validation or qualification experience, must be reputed company to manage multiple reputed company, lacking communication skills, and must be willing to be on site in Thousand Oaks reputed company needed. Why is the Position reputed company? Planned Project. Interview Process: 30 minute Phone Interview with Reporting Manager; 1 Hour In-Person Panel Interview We invite reputed company 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 reputed company this opportunity with anyone you think might be interested in applying for this role. Regards, 3KC reputed company Apply tot his job Apply To this Job