Fusion Life Sciences Technologies LLC ยท 8 hours ago
Validation Engineer
Raynham, MA
Contract
Onsite
New Grad, Entry, Mid Level
0+ years expFusion Life Sciences Technologies LLC is seeking a Validation Engineer to support Project Knight, a large-scale foundry capacity expansion project. The role involves developing and maintaining manufacturing documentation, supporting equipment qualifications and process validations, and ensuring compliance within the Quality System.
Data ManagementLife SciencePharmaceuticalStaffing Agency
Hiring Manager
Srija Pagadakula
Responsibilities
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
Qualification
Required
A minimum of a bachelor's degree in engineering, Science, or related technical field
A minimum of 0-5+ years of related experience
Knowledge of statistical data analysis tools (e.g. Minitab)
Basic knowledge of Geometric Dimensioning and Tolerancing (GD&T)
The ability to perform 'hands on' troubleshooting and problem solving
Knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook)
Strong communication and interpersonal skills
Must have the ability to function in a team-based manufacturing environment
The ability to collaborate with all levels of management in a cross-functional team environment
Preferred
Experience in manufacturing: metal casting processes, CNC machining processes, metal finishing processes, Gage R&R CNC equipment, plastic or wax injection, laser processing or production automation
Experience in a Medical Device work environment
Good technical understanding of manufacturing equipment and processes
Experience working in both an FDA and European regulatory environment in manufacturing/operations
Company
Fusion Life Sciences Technologies LLC
Fusion Life Sciences Technologies (www.fusionlifesolutions.com ) is a WBE-certified Healthcare Staffing and Engineering Services provider supporting industries including Pharma, Medical Devices, Aeronautical, Supply Chain, Heavy/Light Industrial, Food & Beverage, and Automotive.
201-500 employees
H1B Sponsorship
Fusion Life Sciences Technologies LLC has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (57)
2024 (95)
2023 (116)
2022 (135)
2021 (128)
2020 (133)
Funding
Current Stage
Growth StageLeadership Team
R
Rohith Kumar
Executive Partner
Company data provided by crunchbase