Description

Lead technical direction for pharmaceutical capital projects, overseeing process design, equipment lifecycle, and validation from concept through commissioning.

This role is on-site.

Responsibilities

• Translate business requirements into scalable technical solutions for oral solid dosage manufacturing.
• Lead technology selection, capacity modeling, and preliminary equipment sizing.
• Develop and review User Requirement Specifications (URS) to ensure validation readiness.
• Conduct process risk assessments and support supplier selection and bid evaluations.
• Oversee construction-phase audits, Factory Acceptance Testing (FAT), and CQV activities.

Required Skills

• Strong expertise in Oral Solid Dosage (OSD) unit operations (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.
• 5+ years of experience in process engineering.
• Bachelor's degree in engineering or related field.
• Knowledge of FDA, EMA, and cGMP regulatory requirements.
• Strong communication and stakeholder management skills.

Preferred Skills

• Experience in large-scale pharmaceutical capital projects.
• Familiarity with process modeling and capacity analysis tools.
• Experience supporting multi-site or global manufacturing operations.

Key Skills

Education

Bachelor's degree