GMP Project Engineer - Life Sciences Manufacturing

PSC Biotech® Corporation; Boulder (CO); Presencial; USD 100.000 - 120.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, Dental, Vision

401(k) and matching

PTO and Holidays

Education Assistance

Pet Insurance

Fitness perks

Descripción de la vacante

PSC Biotech® Corporation is hiring an experienced Project Engineer to plan, design, execute, and deliver regulated life sciences projects. You will coordinate cross-functional teams across facilities, equipment, and utilities while ensuring GMP, quality, and safety standards are met.

The role requires hands-on project experience in pharmaceutical/biotech environments, strong documentation practices, and the ability to manage multiple priorities in a fast-paced setting.

Formación

• Bachelor's degree in a relevant engineering discipline required.
• 5+ years in pharma/biotech/regulated manufacturing environments.
• GMP experience and FDA-regulated facility exposure.
• Knowledge of GMP docs, change control, deviations, CAPA, and controlled docs.
• Experience coordinating vendors, contractors, and engineering firms.
• Strong project management, organization, communication, and problem-solving skills.
• Able to manage multiple priorities in a fast-paced environment.
• U.S. work authorization; no C2C.

Responsabilidades

• Lead and support engineering projects from concept through design, procurement, installation, commissioning, qualification, and closeout.
• Develop project scopes, schedules, budgets, resource plans, and implementation strategies.
• Coordinate activities across manufacturing equipment, utilities, facilities, labs, automation, and infrastructure.
• Review and prepare URS, design specs, equipment specs, assessments, vendor docs, and turnover packages.
• Ensure projects comply with GMP, site quality systems, and EHS requirements.
• Collaborate with Quality and Validation to incorporate commissioning, qualification, validation and change control.
• Support risk-based planning and equipment implementation for qualification activities.
• Coordinate equipment installation, field work, contractors, vendors, and service providers.
• Review vendor proposals, drawings, submittals, and documentation for project needs.
• Facilitate design reviews, risk assessments, and project meetings; address risks and issues.
• Monitor performance against scope, schedule, budget, quality, and safety objectives.
• Manage engineering changes through change control and document control processes.
• Support startup, commissioning, troubleshooting, and turnover to final owners.
• Maintain clear project documentation and provide status updates to stakeholders.
• Identify opportunities to improve reliability, efficiency, and compliance in projects.

Conocimientos

Cross-functional collaboration

Project management

Communication

Problem solving

Regulatory affairs

Educación

Bachelor's degree in Chemical Eng., Mechanical Eng., Electrical Eng., Biomedical Eng., Biochemical Eng., or related field

Descripción del empleo

PSC Biotech® Corporation is hiring an experienced Project Engineer to plan, design, execute, and deliver regulated life sciences projects. You will coordinate cross-functional teams across facilities, equipment, and utilities while ensuring GMP, quality, and safety standards are met.

The role requires hands-on project experience in pharmaceutical/biotech environments, strong documentation practices, and the ability to manage multiple priorities in a fast-paced setting.