Associate Director, Process Engineering

Quick Facts

• On-site: 5 days per week (USA - GA - Social Circle)

Description

Own site process equipment and ensure it is fit for purpose for GMP drug substance and drug product manufacturing, meeting regulatory, quality, capacity, and EHS requirements.

Lead process technology selection, capacity modeling and site master planning, engineering and equipment design, safety engineering (including PHA/HAZOP), commissioning/turnover documentation, and factory-floor continuous improvement/troubleshooting.

Provide technical leadership for CAPEX investments, equipment acquisition, vendor management, commissioning/qualification/validation support, and management of change.

Responsibilities

• Lead technology selection and evaluation of new process equipment (e.g., robotics, single-use technology)
• Develop business cases for CAPEX using Total Cost of Ownership (TCO)
• Create process unit operation capacity models; identify bottlenecks/constraints in GMP processes and utilities
• Lead front-end engineering and design; manage project scope, design phases, timeline, and budget
• Gather stakeholder requirements (Quality, Manufacturing, Reliability/Maintainability, Automation, EHS) and define basis of design/specifications
• Develop RFx/Scope of Work for process equipment vendors and engineering/commissioning services
• Support commissioning and testing (Factory/Site Acceptance Testing); deliver turnover packages and maintain engineering documentation
• Perform design reviews and lead qualification/validation activities with engineering validation partners
• Conduct Process Hazard Analysis (PHA/HAZOP); incorporate improvements into equipment, control, and safety systems
• Own investigations and implement CAPA for process equipment
• Lead factory-floor troubleshooting and continuous improvement using DMAIC, FMEA, and RCA; perform level 3 troubleshooting and implement improvements
• Manage Change for process equipment and support internal/regulatory audits and inspections

Benefits

• Competitive U.S. base salary range: $154,400.00 - $242,550.00 (actual offer depends on qualifications and experience)
• Benefits available (details provided by employer)