Validation Engineer & Process Development

Role: Validation Engineer & Process Development

Location: Raynham, MA

Duration: 12+ Months

Interview type: Telephonic / video

Description:

We are seeking an experienced Validation Engineer to support manufacturing process development, validation activities, and equipment commissioning within a regulated production environment. The ideal candidate will be responsible for authoring and executing validation documentation, supporting production readiness, and driving process improvements while ensuring compliance with regulatory standards including FDA requirements.

Key Responsibilities

1. Process Validation
   Develop, author, and execute validation protocols and reports including Installation Qualification, Operational Qualification, and Performance Qualification.
2. Manufacturing Process Development
   Support the development and implementation of manufacturing processes including preparation of specifications, operator instructions, and production process documentation.
3. Production Readiness
   Conduct process studies and ensure production readiness for new or modified manufacturing processes.
4. Root Cause Analysis and Problem Solving
   Investigate manufacturing issues, perform root cause analysis, implement corrective actions, and prepare technical reports or presentations.
5. PLM System Updates
   Update manufacturing procedures, specifications, bills of materials, routing documents, and production travelers within the Product Lifecycle Management system.
6. Equipment and Asset Commissioning
   Support commissioning activities for new manufacturing assets and equipment installations.
7. Vendor Collaboration
   Work with OEM equipment manufacturers and distributors to define user requirements and support equipment qualification activities.
8. Cross Functional Collaboration
   Collaborate with operations, planning, engineering, operational excellence, and quality teams to align on validation strategies and process implementation.
9. Validation Documentation Management
   Coordinate the development, execution, and approval of validation documentation across multiple stakeholders.
10. Regulatory Compliance
    Ensure compliance with FDA regulations, company policies, operating procedures, and regulatory standards when supporting manufacturing projects.
11. Communication and Stakeholder Engagement
    Maintain strong communication and collaboration with internal teams, external vendors, contractors, and project stakeholders.

Required Skills

1. Strong experience with manufacturing process validation including IQ, OQ, and PQ documentation and execution.
2. Experience developing and implementing manufacturing processes and production documentation.
3. Experience conducting process studies and supporting production readiness initiatives.
4. Strong knowledge of root cause analysis and problem solving methodologies.
5. Experience working with PLM systems to manage product and manufacturing documentation.
6. Experience working with OEM equipment vendors and supporting equipment commissioning activities.
7. Strong understanding of regulated manufacturing environments including FDA compliance requirements.
8. Excellent communication and collaboration skills across cross functional teams.

Experience Required

1. Minimum 6+ years of experience working as a Manufacturing Engineer in regulated manufacturing environments such as medical devices, pharmaceuticals, or related industries.