Senior Project Engineer - Biopharmaceutical Engineering - Resilience

Key Responsibilities

• Plan, execute, and oversee engineering projects from concept through commissioning in a GMP‑regulated biopharma facility.
• Develop and review design specifications, CAD models, and process flow diagrams to ensure compliance with regulatory standards.
• Lead risk assessments, validation protocols, and qualification activities (IQ/OQ/PQ) for equipment and systems.
• Act as the primary technical advisor, providing guidance to multidisciplinary teams and resolving engineering challenges.
• Monitor project schedules, budgets, and deliverables, reporting status to senior leadership and ensuring milestones are met.

Requirements

• Bachelor’s degree in Mechanical, Chemical, or Biomedical Engineering (or equivalent experience).
• 5+ years of hands‑on project engineering experience in a GMP biopharmaceutical or related high‑tech manufacturing environment.
• Proven expertise in validation, qualification, and risk management methodologies (e.g., FMEA, HACCP).
• Strong knowledge of regulatory requirements (FDA, EMA, ICH) and ability to interpret technical standards.
• Excellent communication, problem‑solving, and leadership skills, with a track record of delivering projects on time and within budget.