Title: Engineer II Duration: 12 Months Location: North Chicago, IL 60045
Job Responsibilities: • Technical support of produce development and leadership at lab study scale up for commercial manufacturing of medical devices, drug device delivery systems, and combination products. • Cross-function engagement and team matrix working experiences in portfolios of drug delivery system product development projects. • Advances in scientific and engineering of medical device related experimental DOE design of experimental activities for the engagements with internal teams and external partners. • Supports the experimental lab execution, data generation and collection, results summary and slide deck preparation and presentation at weekly meeting. • Interface engagement of the project cross-function team and governance process and forward-looking evaluation of potential risk with timely problem solving. • Supports in tech transfer, process development, optimization, and scale-up activities. Work closely with contract manufacturing organizations (CMOs) to ensure technical and operational alignment with company standards. • Plans, designs, executes, documents, and analyzes a regimen of tests to evaluate, verify and/or validate a system. • Provide knowledge in pharmaceutical manufacturing processes, particularly small molecules and biological drug related device delivery systems and combination products • Interface with project and laboratory teams to develop DOE and functional tests, experimental protocols, and new target evaluations. • Assesses risks and creates test plans around risk priorities; analyzes results, states conclusions, and assesses residual risks after tests are complete; in addition, assesses adequacy of support for conclusions by test results. • Understands regulations, apply guidance and standards on design verification and design validation to test activities and work products; prepares documentation for compliance with standard operating procedures • Develop and review technical documentation, including standard operating procedures (SOPs), batch records, and validation protocols. • Troubleshoot manufacturing challenges and support investigations into deviations or process failures. • Collaborate cross-functionally with marketing, quality, regulatory, and supply chain teams to ensure seamless operations. • Stay up to date with industry trends and best practices in pharmaceutical product development and lab, pilot and scale up manufacturing and commercial production.
Qualifications
• BS degree as minimum requirements of 1-5 years (MS preferred and PhD acceptable) in the field of biomedical, mechanical, chemical, materials science and engineering, biotechnology and pharmaceutical related engineering fields. • Experience in developing medical devices, device-drug delivery systems, and/or combination products. Broad experience in product and process design, development, design verification and design validation and patient usability applications. • Product development experience and commercial scale manufacturing knowledge are a must have. Strong understanding of electromechanical device development and process techniques, including design, development, lab testing, and drug-device interaction and system testing. • Familiarity with cGMP, regulatory requirements (FDA, EMA), and quality assurance practices in medical device, drug-device systems and combination products biomanufacturing. • Hands-on experience working with contract manufacturing organizations (CMOs) requirements is a plus. • Excellent problem-solving skills and ability to work in a fast-paced environment. • Strong communication and collaboration skills to effectively engage with internal and external stakeholders. • Excellent problem-solving skills and ability to work in a fast-paced environment. Strong communication and collaboration skills to effectively engage with internal and external stakeholders. • Prior experience in technology transfer and process validation preferred. Prior knowledge of analytical methods and process development and characterization preferred. • Broad knowledge in design controls, human factors studies, design verification/validation and usability studies.
Education: • BS degree as minimum requirements of 1-5 years • MS preferred 0-3 yrs • PhD acceptable in 0-3 yrs Ability to Commute: • North Chicago, IL 60064 (Preferred) Work Location: In person on site M-F
Applicant Notices & Disclaimers
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.This position's pay range is $39.00/hr - $40.00/hr.
