- Senior Process Engineer / CQV Validation Engineer
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
Key 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.
CQV, Qualification & Validation - 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 Author, revise, and support approval of technical documentation including:
- Standard Operating Procedures (SOPs)
- Batch Records
- Manufacturing Instructions
- Process Evaluation Reports
- Process Characterization Protocols and Reports
- Process Validation Protocols and Reports
- Equipment Qualification Documentation
- System Verification Documentation
- Engineering Study Protocols and Reports
- Risk Assessments
- Technical Assessments
- Change Controls
- User Requirements and supporting qualification documentation
Required Qualifications:
- 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.
