Engineer
Randstad - waltham, MA
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engineer. waltham, massachusetts posted today job details summary $52.60 - $73.64 per hour contract bachelor degree category computer and mathematical occupations reference job details job summary A Engineer is needed for a research-driven biopharmaceutical company in the Waltham, MA area. The role involves leading manufacturing process improvement projects, conducting data analysis, troubleshooting, and ensuring compliance in pharmaceutical production, while providing technical support, managing small projects, and maintaining documentation for regulatory standards. location: Waltham, Massachusetts job type: Contract salary: $52.60 - 73.64 per hour work hours: 8am to 5pm education: Bachelors responsibilities Lead projects in manufacturing processes to achieve: Increased process yield Quality improvements Reduced cycle time/throughput Cost reduction initiatives Gather and analyze process data using statistical process control methods. Develop action plans to: Increase process robustness Prevent product loss Control quality impact Participate in process performance monitoring activities such as "Track & Trend." Provide technical support for resolving shop floor issues and execute assigned tasks as required. Lead investigations using a structured problem-solving approach, ing scientific principles to: Identify root causes Develop recommendations for product and process improvement Generate technical justifications to support/document: Process deviations and investigations Impact assessments on product quality, yield, and registration Work with cross-functional teams on implementing site projects/initiatives, including: Continuous improvement efforts Cost reduction measures Capacity increases Manage small team projects or short-duration projects within larger initiatives, including: Project coordination Monitoring and reporting Meeting management Team communication Lead the implementation of process validation for: Operational changes New raw materials New process/technology introduction Generate technical justifications to determine the impact of changes and create protocols, reports, and manufacturing documents. Support experimental, demonstration, and validation runs. Maintain up-to-date product process documentation, ensuring compliance with applicable procedures and regulations. Write justification memos and scientific reports related to quality controls and manufacturing documents. Provide scientific and technical support during regulatory audits and inspections. Demonstrate accountability and responsibility for EHS (Environmental, Health, and Safety) performance and compliance through active participation. Qualifications BS or MS in Chemistry or Engineering (Chemical, Mechanical, Bio-chemical) 5-7 years of technical experience in Process/Manufacturing/Project Engineering or a similar role strong technical knowledge of pharmaceutical solid dosage form processing Effective verbal and written communication skills in both English and Spanish Scope of Work Provide technical support in resolving shop floor situations and executing assigned tasks. Analyze process data using statistical process control methods. Develop action plans for process robustness, loss prevention, and quality control. Lead investigations to identify root causes and make recommendations. Document process changes with technical justifications. Support the execution of experimental, engineering, or process validation runs. Maintain compliance of process documentation, including manufacturing directions, batch records, and SOPs. Generate and review reports for regulatory agencies, such as Annual Product Reviews. Capabilities In-depth knowledge of pharmaceutical manufacturing processes Skills in structured problem solving, continuous improvement, and project coordination Proficiency in technical writing qualifications Experience level: Experienced Education: Bachelors skills Project Management Quality Control Data Analysis PharmaceuticalEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact (see below) offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).This posting is open for thirty (30) days.
Created: 2024-10-20