Senior Biopharma Process Engineer – Facility Fit and Layout

Energy Jobline ZR; Durham (NC); In loco; USD 110.000 - 170.000; Tempo pieno

Descrizione del lavoro

Energy Jobline ZR seeks a senior process/facility engineer to support a facility-fit study in a regulated biopharmaceutical manufacturing environment. The role evaluates planned equipment against an existing GMP suite, develops layouts, and identifies facility and utility gaps.

Collaboration with Process, Manufacturing, MSAT, Facilities, and Validation SMEs is essential. The ideal candidate will independently drive technical discussions, review equipment specs, and contribute to preliminary cost

Competenze

• Biopharmaceutical engineering experience in GMP environments.
• Experience evaluating equipment against facility capabilities.
• Experience performing facility-fit or gap assessments.
• Experience developing or reviewing GMP process layouts and layouts.
• Experience supporting upstream/downstream bioprocess environments.
• Knowledge of biopharma utility requirements.
• Experience developing User Requirement Specifications (URS).
• Understanding commissioning, qualification, and validation (CQV).
• Ability to contribute to early cost estimates and schedules.
• Ability to lead cross-functional discussions with SMEs.

Mansioni

• Review equipment specs and assess fit within GMP environments.
• Develop preliminary facility layouts and evaluate personnel/material flow.
• Identify facility gaps and propose modifications.
• Support URS development and early cost/schedule estimates.
• Lead technical discussions with Manufacturing, MSAT, Facilities, and Validation.

Conoscenze

Biopharmaceutical engineering

Process equipment integration

Facility fit / gap assessments

Process layout

USP / DSP

Utilities

URS development

CQV awareness

Cost / schedule

Cross-functional leadership

Descrizione del lavoro

Energy Jobline ZR seeks a senior process/facility engineer to support a facility-fit study in a regulated biopharmaceutical manufacturing environment. The role evaluates planned equipment against an existing GMP suite, develops layouts, and identifies facility and utility gaps.

Collaboration with Process, Manufacturing, MSAT, Facilities, and Validation SMEs is essential. The ideal candidate will independently drive technical discussions, review equipment specs, and contribute to preliminary cost