Senior Process Engineer

Job Description

Position Summary

A leading biopharmaceutical company is seeking an experienced Senior Process Engineer to support the design, development, and implementation of process systems for advanced biotechnology and pharmaceutical manufacturing facilities. This role will focus on front-end engineering design (FEED), process design, facility expansion projects, and the optimization of manufacturing operations.

The successful candidate will have a strong background in biotech or pharmaceutical process engineering, facility design, and capital project execution, with experience supporting both new facility builds and existing manufacturing operations.

Key Responsibilities

Lead and support Front-End Engineering Design (FEED) activities for biotechnology and pharmaceutical manufacturing facilities.
Develop process flow diagrams (PFDs), process and instrumentation diagrams (P&IDs), mass balances, and process design documentation.
Provide technical leadership for process equipment selection, specification, and integration.
Collaborate with cross-functional teams including Manufacturing, Quality, Validation, Automation, Facilities, and Project Management.
Support conceptual, basic, and detailed design phases for facility expansions, renovations, and greenfield projects.
Conduct process evaluations, capacity assessments, and operational improvement initiatives.
Participate in design reviews, HAZOPs, risk assessments, and engineering studies.
Ensure designs comply with cGMP, FDA, EMA, and industry standards.
Support commissioning, start-up, and technology transfer activities as required.
Interface with external engineering firms, contractors, and equipment vendors throughout project execution.

Qualifications

Bachelor's degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related discipline. Advanced degree preferred.
10+ years of process engineering experience within biotechnology, pharmaceutical, or biologics manufacturing environments.
Demonstrated experience with FEED and facility design projects.
Strong understanding of bioprocessing operations, clean utilities, process equipment, and facility infrastructure.
Experience supporting capital projects from concept through implementation.
Familiarity with cGMP regulations and pharmaceutical manufacturing requirements.
Excellent communication, stakeholder management, and problem-solving skills.

Preferred Experience

Biologics, cell culture, fermentation, protein purification, or advanced therapeutics manufacturing.
Large-scale biotech facility design and expansion projects.
Experience working with engineering consulting firms, EPC/EPCM organizations, or owner-side capital project teams.
Knowledge of process simulation, facility fit studies, and process optimization methodologies.