Senior Process / Facility Engineer

United Pharma; New Jersey; On-site; USD 120,000 - 180,000; Full time

Job summary

United Pharma is seeking a Senior Process / Facility Fit Engineer to drive facility-fit assessments and front-end engineering in a GMP biopharmaceutical manufacturing environment. You will evaluate equipment and process requirements against existing facilities to craft practical implementation solutions.

Collaborating with Process Engineering, Manufacturing, MSAT, Facilities, Validation, Quality, and other SMEs, you will help develop URS, cost estimates, and execution plans, while supporting CQV

Qualifications

• Experience in process engineering, facility fit, and equipment integration in biopharmaceuticals.
• GMP-regulated manufacturing environments experience required.
• Knowledge of USP/DSP process equipment, facility layouts, utilities and manufacturing flows.

Responsibilities

• Conduct facility-fit studies for new process equipment within existing GMP suites.
• Review equipment specifications, footprints, utilities, and technical requirements for facility compatibility.
• Develop GMP process layouts including equipment placement, accessibility, ergonomics, and maintenance.
• Perform facility and utility gap assessments and identify constraints for installation and operation.
• Assess utilities (process utilities, clean utilities, electrical, HVAC, facility services) requirements.
• Recommend facility modifications and infrastructure improvements for new equipment or processes.
• Support development of preliminary URS requirements for equipment and facility changes.
• Develop preliminary project cost estimates, schedules, and execution plans for modifications.
• Collaborate with Engineering, Manufacturing, MSAT, Facilities, Validation, Quality and SMEs to resolve gaps.
• Support CQV activities considering commissioning, qualification, and validation for equipment and changes.

Skills

Process engineering

Facility fit

Equipment integration

Biopharmaceutical manufacturing

GMP environments

Cross-functional collaboration

Technical communication

Problem solving

Stakeholder management

Job description

We are seeking a Senior Process / Facility Fit Engineer to support facility-fit assessments, process equipment integration, and front-end engineering activities within a GMP-regulated biopharmaceutical manufacturing environment. This role will evaluate equipment and process requirements against existing facilities and develop practical engineering solutions for implementation.

Key Responsibilities:

• Conduct facility-fit studies for new process equipment within existing GMP manufacturing suites.
• Review equipment specifications, footprints, capacities, utilities, and technical requirements to confirm facility compatibility.
• Develop and review GMP process layouts, including equipment placement, accessibility, ergonomics, and maintenance requirements.
• Perform facility and utility gap assessments and identify constraints affecting equipment installation and operation.
• Assess utility requirements for biopharmaceutical equipment, including process utilities, clean utilities, electrical, HVAC, and facility services.
• Recommend facility modifications and infrastructure improvements required to support new equipment or processes.
• Support development of preliminary URS requirements for equipment, facility modifications, and engineering solutions.
• Develop preliminary project cost estimates, implementation schedules, and execution plans for equipment and facility modifications.
• Collaborate with Process Engineering, Manufacturing, MSAT, Facilities, Validation, Quality, and technical SMEs to gather requirements and resolve technical gaps.
• Support CQV activities, considering commissioning, qualification, and validation requirements for equipment and facility changes.

Key Qualifications:

• Strong experience in process engineering, facility fit, equipment integration, or biopharmaceutical manufacturing.
• Experience working in GMP-regulated manufacturing environments.
• Knowledge of USP/DSP process equipment, facility layouts, utilities, and manufacturing flows.
• Experience with facility and utility assessments, URS development, and engineering gap analysis.
• Understanding of CQV requirements for equipment and facility modifications.
• Strong ability to collaborate across Engineering, Manufacturing, MSAT, Facilities, Validation, and Quality teams.
• Excellent technical communication, problem-solving, and stakeholder-management skills.