Senior Process Engineer / CQV Validation Engineer at Validation & Engineering Group, Inc. in Hialeah, FL

Job description

• This is a hands-on role for a senior professional capable of independently executing and driving process engineering, qualification, validation, and GMP documentation deliverables while supporting ongoing manufacturing operations and strategic projects.
• Schedule: Approximately 40 hours per week, with flexibility to support additional hours when required to meet project milestones, validation schedules, and manufacturing needs
• Work Model: Primarily on-site. Limited remote work may be permitted based on project requirements and management approval

Responsibilities

• Process Engineering & Manufacturing Support
• Lead and execute manufacturing process characterization studies.
• Perform process capability assessments and data analysis.
• Conduct manufacturing line evaluations and performance assessments.
• Support process optimization and continuous improvement initiatives.
• Provide equipment startup, troubleshooting, and operational readiness support.
• Lead root cause investigations and support implementation of corrective actions.
• Develop and execute engineering studies supporting manufacturing objectives and process improvements.
• Collaborate with Manufacturing, Operations, Engineering, Maintenance, and Quality teams.
• Develop and execute IQ, OQ, and PQ protocols.
• Support qualification of new and existing manufacturing equipment and systems.
• Execute system verification and validation activities.
• Lead process validation planning, execution, data analysis, and reporting.
• Provide commissioning and qualification support.
• Support the full validation lifecycle from planning and protocol development through execution, deviation resolution, and final report approval.
• Manage protocol deviations, exceptions, and associated investigations.
• Support change control assessments and implementation activities.
• Develop validation summary reports and final project deliverables.
• GMP Documentation
• Standard Operating Procedures (SOPs)
• Batch Records
• Manufacturing Instructions
• Process Evaluation Reports
• Process Characterization Protocols and Reports
• Process Validation Protocols and Reports
• System Verification Documentation
• Engineering Study Protocols and Reports
• Risk Assessments
• Technical Assessments
• Change Controls
• User Requirements and supporting qualification documentation

Requirements

• Minimum 5 years of experience in Process Engineering, Validation, CQV, Manufacturing Engineering, or a related discipline.
• Experience within Medical Device, IVD, Diagnostics, Biotechnology, Pharmaceutical, or another FDA-regulated manufacturing environment.
• Strong understanding of GMP requirements and regulated documentation practices.
• Demonstrated experience authoring and executing IQ/OQ/PQ protocols.
• Hands-on experience with process characterization and process validation.
• Experience supporting equipment qualification and system verification.
• Strong technical writing and documentation skills.
• Experience with change controls, deviations, CAPAs, and risk assessments.
• Strong analytical, troubleshooting, and problem-solving skills.
• Ability to independently manage deliverables and collaborate effectively across multiple functional groups.

Skills

Required

• Process Engineering
• Validation
• CQV
• Manufacturing Engineering
• GMP requirements
• Regulated documentation practices
• Process characterization
• Process validation
• Equipment qualification
• System verification
• Change controls
• Deviations