Engineer

Job Title: Engineer IIDuration: 12 Months (possibility of extension)Location: Cambridge, MA 02142Schedule: Mon- Fri 9am – 5pm Pay range: $31-$41/hr on W2Job Description:The Engineer II (MTS) will be a part of the internal Manufacturing Technical Services team; your support of critical activities within our team will help us bring our RNAi technology to patients.You will be contributing to the DP technology transfer team to ensure robust manufacturing of our commercial drug products.Key Responsibilities:Support Technology Transfer Activities: Assist in process scale-up, optimization, and technology transfer efforts for new drug product manufacturing at contract manufacturing organizations (CMOs). Participate in due diligence and technical assessments to ensure readiness for transfer.Manufacturing Support: Help assess deviations, contribute to change control documentation, and support CAPA development and risk assessments related to drug product manufacturing under guidance from senior staff.Data Analysis and Trending: Participate in routine process data collection and trending activities. Assist in preparing summaries and visualizations for internal reviews and management presentations.Continuous Improvement: Identify opportunities for process improvements and contribute to implementation plans. Collaborate with cross-functional teams to evaluate regulatory and operational impacts of proposed changes.Validation and Launch Support: Support the development of process validation protocols and sampling plans. Assist in execution and documentation of validation activities to meet GMP requirements.Demonstrates competency in the principles and practice of cGMPs and associated regulatory considerations in a pharmaceutical environment, including process, equipment, and facility validation experienceAssist in the execution of development experiments in the lab as needed.Ensure commercial drug product manufacturing readiness prior to each lot.Support timely closure of deviations, investigations and CAPAsContribute to authoring process control documentationCommunicate updates to key cross functional teamsContributions to Manufacturing department and company goals and objectives.Education and Qualifications:B.S. in applicable science field 2+ years of experience in a laboratory setting Competence with MS Word, Excel, and PowerPointB.S. in applicable science field 2+ years of experience in a laboratory setting Competence with MS Word, Excel, and PowerPointData Trending experience (Excel, JMP) is desirableRequired Skills:Ability to work independently Excellent team skills, organization, collaborative spirit, and strong communication skills (written and verbal)Ability to maneuver through changing priorities Experience or exposure to working in GMP environments is desired Must be able to adhere to all laboratory safety requirements Ability to travel between domestic Client sites is helpful (Kendall, Alewife and Norton)May be required to lift objects up to 50lbsDexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals. Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit https://dexian.com/ to learn more. Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.