Current Openings

Developing, writing, reviewing, maintaining and revising manufacturing documentation, i.e. Process Work Instructions, Manufacturing Specifications, Inspection Procedures to support product Manufacturing .Supporting the development and execution of manufacturing equipment qualifications (URS/FAT/SAT/IQ) .Supporting the development and execution of process validations (OQ/PQ/PV).Developing, writing, and reviewing various validation deliverables, i.e. CSV-E, Engineering Studies, etc.Assessing, developing, writing, executing, and reviewing Test Method Validations (TMVs’).Developing, writing, reviewing, and updating relevant Process RisK Documentation (pRAS, pFMEA, FMCA).Partnering with cross functional partners to ensure sound validation strategy and smooth transitions to production go-live.Ensuring adequate documentation where necessary within the Quality System.Participate as an integral member of cross-functional product teams by contributing ideas as well as designing, managing or executing, and interpreting device development activities.Provide engineering support to evaluate, mitigate, re-certify and maintain compliance of the group’s products with new global regulations.Collaborate with cross functions within and outside the group to develop and execute mitigation projects.Manages routine small projects without assistance.Coordinate day-to-day operations of engineering and technical staff assigned to projects by assigning, monitoring and reviewing progress and accuracy of work, directing efforts, and providing technical guidance.The qualifications for this assignment require a minimum Bachelor in Mechanical Engineering or equivalent or any other related degree

Work Location: Raynham, Massachusetts 02767

Salary: $50.00/hr

To apply to the position, send your resume to: hr@fusionlifesolutions.com

Core Competencies & Execution,Autonomous Leadership: Acts as a self-starter with minimal supervision, driving validation workstreams independently while maintaining frequent synchronization with immediate supervisors.Cross-Functional Collaboration: Builds high-trust, collaborative relationships with R&D scientists, manufacturing teams, and quality assurance personnel to achieve agile team goals in a fast-paced biotech setting.Technical Execution & Compliance.Lifecycle Management: Maintains equipment systems in a qualified state by strictly adhering to Denali’s policies, SOPs, and change management procedures.Protocol Development: Authors and executes comprehensive qualification protocols (IQ/OQ/PQ) and summary reports for diverse assets, including analytical instruments, manufacturing skids, and facility utilities.Thermal Validation: Performs rigorous temperature mapping of Controlled Temperature Units (CTUs)—such as freezers, incubators, and stability chambers—utilizing wired or wireless mapping systems (e.g., Kaye Validator, Kaye ValProbes, Ellab).Vendor Management: Supervises OEM vendors and third-party contractors during site acceptance testing (SAT) and qualification activities to ensure deliverables meet internal quality standards.Capital Project Support: Manages projects of defined scope, assisting with equipment implementation from scheduling and procurement through site preparation, installation, qualification, and final turnover to the business owner.Data Integrity: Ensures all qualification and validation documentation is generated with 100% accuracy, completeness, and compliance with Good Documentation Practices (GDP) and Denali’s quality standards.The qualifications for this assignment require a minimum Bachelor of Mechanical Engineering or equivalent or any other related degree

Work Location: Salt Lake City, Utah 84116

Salary: $47.60/hr

To apply to the position, send your resume to: hr@fusionlifesolutions.com