Manufacturing Validation Engineer

Role – Manufacturing Validation Engineer

Location – Raynham, MA (Onsite)

Exp need – 8+ years

• Writing and execution of validation protocols and reports (i.e. IQ| OQ| PQ| etc.)
• Developing and implementing manufacturing processes| preparation of specifications and operator instructions| process studies| production readiness| investigations| root cause analysis| problem solving and report or presentation preparation.
• Updating procedures| manufacturing specifications| bills| routes and travelers for product process changes in the PLM system.
• Working with OEM equipment manufacturers and distributors to develop user requirements.
• Work on new asset commissioning
• Working with multi-functional teams (Operations Value Stream| OpEx| Planning| Engineering| and Quality) to align on validation strategy| author validation documents| coordinate execution and document approvals.
• Ensuring compliance with U.S. Food and Drug Administration (FDA) regulations| other regulatory requirements| Company policies| operating procedures| processes| and task assignments when supporting projects.
• Maintains positive and cooperative communication and collaboration with all levels of employees| customers| contractors| and vendors

Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.