Position Summary:
We are seeking an experienced Senior Process/Project Engineer to lead and manage engineering projects related to the development and manufacturing of Active Pharmaceutical Ingredients (API). The role will focus on process optimization, technical troubleshooting, project execution, and cross-functional leadership. The ideal candidate brings significant expertise in API process engineering and has over 10 years of experience in the pharmaceutical or chemical manufacturing industry.
Key Responsibilities:
Lead and manage end-to-end engineering projects for API manufacturing, from conceptual design to commissioning and handover.
Develop and optimize process designs, ensuring efficiency, scalability, and compliance with regulatory standards (FDA, EMA, etc.).
Prepare project plans, detailed schedules, budgets, and resource allocations; monitor progress against milestones.
Coordinate and lead cross-functional teams (including R&D, production, quality, EHS, and external vendors/contractors).
Review and approve process documentation, PFDs, P&IDs, and engineering drawings.
Lead process safety and HAZOP reviews; ensure strict adherence to safety protocols.
Identify and implement process improvements for yield, quality, and cost reduction.
Provide technical support for troubleshooting and resolution of complex process issues.
Oversee commissioning, qualification, and validation of new or modified API processes and equipment.
Drive cGMP compliance and maintain up-to-date knowledge of industry standards.
Mentor junior engineers and support technical knowledge development within the team.
Engage with key stakeholders to deliver successful project outcomes on time and within budget.
Requirements:
Bachelor’s or Master’s degree in Chemical Engineering, Process Engineering, or related field.
Minimum of 10 years relevant experience in process/project engineering for API manufacturing (pharmaceutical or chemical industry).
Proven track record of leading complex engineering projects and cross-functional teams.
Deep knowledge of process design, scale-up, and technology transfer for API production.
Strong understanding of cGMP, regulatory compliance, and industry guidelines (FDA, EMA, ICH, etc.).
Proficient in process modeling and simulation tools; experienced with common engineering software (e.g., Aspen, AutoCAD).
Demonstrated leadership, organizational, and communication skills.
Experience in risk management including HAZOP, root cause analysis, and implementation of corrective actions.
Ability to manage multiple priorities and deliver results under tight timelines.
Excellent problem-solving and decision‑making capability.
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