Senior Process Engineer / CQV Validation Engineer

About the role

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position: 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. Work model: primarily on-site; limited remote work may be permitted based on project requirements and management approval.

Responsibilities

• 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.
• Author, revise, and support approval of technical documentation including 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.

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.

Schedule

Approximately 40 hours per week, with flexibility to support additional hours when required to meet project milestones, validation schedules, and manufacturing needs.