Senior Engineer-35381

ProQuality Network; United States; Hybrid; USD 90,000 - 130,000; Full time

Job summary

ProQuality Network seeks a Senior Engineer to provide technical leadership for manufacturing operations in a regulated environment. You will support process improvements, capital projects, system modifications, and troubleshooting while ensuring quality and regulatory alignment.

You will lead cross-functional teams, develop technical solutions, perform root cause investigations, and manage project delivery from planning to startup.

Qualifications

• Master's degree with 2+ years of engineering experience or Bachelor's degree in Engineering with 4+ years.
• Preferred: degree in Chemical, Mechanical, Industrial, Biotechnology or related engineering discipline.

Responsibilities

• Lead and support projects related to manufacturing processes, equipment, facilities, and operational improvements.
• Develop and implement technical solutions for complex process, equipment, and system challenges.
• Perform assessments, root cause investigations, risk evaluations, and corrective actions.
• Collaborate with Manufacturing, Quality, Process Development, Validation, Utilities, Facilities, and Maintenance teams.
• Support design, installation, commissioning, qualification, and startup of new or modified systems and equipment.
• Manage engineering deliverables to ensure projects meet scope, timelines, budgets, and quality.

Skills

Problem solving

Cross-functional collaboration

Analytical skills

Project management

Technical writing

Lean Six Sigma

Root Cause Analysis

Education

Master's degree in engineering

Bachelor's degree in engineering

Tools

Automation systems

Job description

The Senior Engineer provides technical leadership and engineering support for manufacturing operations, process improvements, capital projects, system modifications, and troubleshooting activities within a regulated pharmaceutical or biotechnology environment. This role applies advanced engineering principles to solve complex technical challenges, improve operational performance, and support cross-functional initiatives while ensuring compliance with quality and regulatory requirements.

Key Responsibilities

• Lead and support engineering projects related to manufacturing processes, equipment, facilities, and operational improvements.
• Develop and implement technical solutions for complex process, equipment, and system challenges.
• Perform engineering assessments, root cause investigations, risk evaluations, and corrective action implementation.
• Collaborate with Manufacturing, Quality, Process Development, Validation, Utilities, Facilities, and Maintenance teams to support business objectives.
• Support design, installation, commissioning, qualification, and startup activities for new or modified systems and equipment.
• Manage engineering deliverables to ensure projects are completed within established scope, timelines, budgets, and quality requirements.
• Coordinate activities with contractors, vendors, consultants, and engineering firms as required.
• Prepare and review technical documentation, engineering reports, protocols, specifications, and presentations.
• Support process optimization, continuous improvement, and operational excellence initiatives.
• Participate in project planning, scheduling, budgeting, and execution activities.

Required Qualifications

• Master's degree with 2+ years of Engineering experience; OR
• Bachelor's degree in Engineering with 4+ years of Engineering experience.

Preferred Qualifications

• Degree in Chemical Engineering, Mechanical Engineering, Industrial Engineering, Biotechnology, or a related engineering discipline.
• Experience supporting manufacturing, process engineering, production systems, or capital projects within pharmaceutical, biotechnology, medical device, or other highly regulated industries.
• Knowledge of process validation, equipment qualification, commissioning, and startup activities.
• Familiarity with automation systems, manufacturing equipment, and process technologies.
• Experience with continuous improvement methodologies such as Lean Manufacturing, Six Sigma, Kaizen, and Root Cause Analysis.
• Understanding of cGMP regulations, compliance requirements, and Good Documentation Practices (GDP).
• Strong engineering problem-solving and analytical skills.
• Ability to troubleshoot complex manufacturing and process-related issues.
• Experience leading technical initiatives and supporting cross-functional teams.
• Project management and schedule coordination capabilities.
• Strong technical writing, presentation, and communication skills.
• Ability to manage multiple priorities and projects simultaneously.
• Effective collaboration with operations, quality, validation, maintenance, and engineering teams.
• Experience managing contractors, vendors, and external resources.
• Adaptability, leadership, and sound decision-making skills in a fast-paced environment.

This position requires a hands-on engineering professional capable of independently driving technical solutions, supporting manufacturing operations, and delivering engineering projects in compliance with quality, safety, and regulatory expectations.