Description

Key Responsibilities

• Provide technical leadership and direction across process engineering activities for capital projects
• Translate business and operational requirements into robust, scalable technical solutions
• Lead technology selection, capacity modeling, and preliminary equipment sizing
• Develop and review User Requirement Specifications (URS) to ensure accuracy and readiness for validation
• Conduct and lead process risk assessments to ensure safety, quality, and compliance
• Support supplier selection, procurement activities, and bid evaluations
• Collaborate with equipment vendors, engineering firms, and construction teams to deliver integrated manufacturing systems
• Review and approve process design documents and vendor technical submittals
• Perform construction-phase technical audits and oversee Factory Acceptance Testing (FAT)
• Support commissioning, qualification, and validation (CQV) activities for GMP equipment
• Provide ongoing technical support to manufacturing sites and external partners to optimize process performance

Required Qualifications

• Strong technical expertise in Oral Solid Dosage (OSD) unit operations (e.g., blending, granulation, compression, coating, packaging)
• Experience with GMP equipment lifecycle: specification, procurement, installation, commissioning, and qualification
• Proven ability to lead technical decision-making on complex capital projects
• Strong communication and stakeholder management skills across cross-functional teams
• Experience working with equipment suppliers, EPC firms, and manufacturing operations

Preferred Qualifications

• Experience in large-scale pharmaceutical capital projects
• Familiarity with process modeling and capacity analysis tools
• Knowledge of regulatory requirements (FDA, EMA, cGMP)
• Experience supporting multi-site or global manufacturing operations

Key Skills

Education

Bachelor's degree