Senior Engineer (3599218)

ProQuality Network; United States; Hybrid; USD 110,000 - 160,000; Full time

Job summary

ProQuality Network is seeking a Senior Engineer to lead process optimization, troubleshooting, and capital projects in a regulated pharmaceutical/biotech manufacturing setting. The role focuses on applying advanced engineering principles to manufacturing operations, pilot plants, and packaging systems with strong collaboration across functions.

The ideal candidate will bring extensive project management and analytical problem-solving abilities, with comfort working in fast-paced environments and

Qualifications

• Experience in pharmaceutical/biotech regulated environments is preferred.
• Strong grasp of GMP and GDP practices and regulatory documentation.
• Ability to manage multiple complex projects with minimal supervision.
• Excellent technical writing and presentation skills.

Responsibilities

• Lead and execute advanced engineering assignments for process optimization and operational improvements.
• Develop and implement engineering procedures, standards, and process improvements.
• Apply engineering principles to troubleshoot and resolve manufacturing challenges.
• Interpret data, investigations, and recommendations to support decisions.
• Coordinate engineers, technicians, contractors, and vendors across projects.
• Support capital projects, validation activities, and packaging initiatives.

Skills

Process optimization

Technical troubleshooting

Engineering design

Project management

Analytical problem-solving

Cross-functional collaboration

Technical writing

Education

Doctorate Degree in Engineering

Master’s Degree in Engineering

Bachelor’s Degree in Engineering

Tools

AutoCAD

Adobe Illustrator

SolidWorks

Job description

Schedule: 100% Onsite – Administrative Shift

Flexibility: Must be available to support non-standard shifts based on manufacturing and production needs

Contract Duration: Approximately 1 Year

Open Positions: 1

Position Summary

Our client is seeking a highly motivated Senior Engineer to support process optimization, technical troubleshooting, engineering design, validation, and capital project initiatives within a regulated pharmaceutical or biotechnology manufacturing environment.

The selected candidate will independently lead and support engineering projects of significant scope and complexity, applying advanced engineering principles to manufacturing operations, pilot plant activities, process improvements, packaging systems, and facility modifications. This role requires strong technical expertise, project management capabilities, analytical problem-solving skills, and the ability to collaborate effectively across multiple functional areas.

The ideal candidate must be comfortable working in fast-paced, evolving manufacturing environments and demonstrate flexibility to support operational needs outside standard business hours when required.

Key Responsibilities

• Lead and execute complex engineering assignments involving process optimization, troubleshooting, system modifications, and operational improvements.
• Develop and implement engineering procedures, technical standards, and process improvement strategies that support multiple functional areas.
• Apply advanced engineering principles and technical expertise to solve manufacturing and operational challenges.
• Interpret, analyze, and present technical data, investigation findings, and engineering recommendations to support business decisions.
• Coordinate and review the work of engineers, technicians, contractors, and consultants on project-based and ongoing activities.
• Serve as a technical subject matter expert in one or more engineering disciplines.
• Support capital projects, process engineering initiatives, and validation activities within regulated environments.
• Collaborate cross-functionally with Manufacturing, Process Development, Quality, Validation, Utilities, Facilities, and Supply Chain teams.
• Develop technical solutions to complex engineering and packaging challenges using creative problem-solving and analytical approaches.
• Support the design, evaluation, testing, and qualification of packaging systems and materials used in healthcare and pharmaceutical applications.
• Work with project managers to execute engineering projects within scope, schedule, budget, and quality expectations.
• Coordinate external consultants, engineering firms, and vendors during project execution and development of engineering documentation.
• Develop and support departmental and project budgets as needed.
• Author and execute technical protocols, engineering evaluations, material testing plans, and technical reports supporting packaging and material selection activities.
• Support engineering drawing development, modification, and approval activities using software such as AutoCAD, Adobe Illustrator, SolidWorks, or similar tools.

Preferred Qualifications

• Experience supporting pharmaceutical, biotechnology, medical device, or highly regulated manufacturing environments.
• Strong understanding of packaging systems, material science, and structural packaging components used in healthcare applications.
• Experience with distribution testing standards and regulatory frameworks, including:
• Hands-on knowledge of packaging components and materials, including: Labels, Trays, Lidding materials, Leaflets, Paperboard, Sterile barrier packaging, Corrugate systems
• Familiarity with validation processes, protocol execution, and regulated documentation practices.
• Strong knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Ability to independently manage projects, priorities, timelines, and technical deliverables.
• Strong technical writing, presentation, communication, and organizational skills.
• Proven ability to work collaboratively within cross-functional and evolving environments.

Education Requirements

Candidates must meet one of the following requirements:

• Doctorate Degree in Engineering or related technical discipline OR
• Master’s Degree in Engineering plus 2 years of relevant engineering experience OR
• Bachelor’s Degree in Engineering plus 4 years of relevant engineering experience

Technical & Engineering Skills

• Working knowledge of pharmaceutical and biotechnology manufacturing processes
• Experience with validation processes and protocol execution
• Knowledge of regulated documentation systems and compliance environments
• Ability to interpret and apply GMP and GLP regulations
• Experience applying engineering science principles to manufacturing operations
• Technical troubleshooting and root cause analysis experience
• Ability to develop practical engineering solutions to technical challenges
• Familiarity with specialized laboratory or manufacturing equipment

Project & Analytical Skills

• Strong analytical problem-solving capabilities
• Technical report writing and documentation skills
• Validation protocol writing and execution experience
• Ability to manage multiple projects simultaneously
• Schedule development and project coordination skills
• Basic project management and cost analysis experience
• Ability to identify when additional internal or external technical resources are required

Leadership & Communication Skills

• Strong verbal and written communication abilities
• Collaboration and cross-functional teamwork experience
• Leadership and team-building capabilities
• Contractor and vendor management experience
• Negotiation, facilitation, and conflict resolution skills
• Ability to adapt to changing priorities and operational demands

Additional Information

This position requires onsite support in Puerto Rico on an administrative schedule, with flexibility to support non-standard shifts based on manufacturing and production demands. The role offers the opportunity to contribute to impactful engineering and process improvement initiatives within a highly regulated and technically advanced environment.