Senior Process/Facility Engineer
Job in
Woodbridge Township, Middlesex County, New Jersey, 07095, USA
Listed on 2026-09-25
Listing for:
United Pharma
Full Time
position Listed on 2026-09-25
Job specializations:
-
Engineering
Process Engineer, Validation Engineer, Quality Engineering, Pharma Engineer
Job Description & How to Apply Below
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.
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.
Position Requirements
10+ Years
work experience
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