Executive - Process Engineering
On-site · Digwal, State of Telangāna, Republic of India
Job Summary
Executive - Process Engineering to lead and optimize pharmaceutical manufacturing processes from concept to commercialization; oversee the design, development, and optimization of processes; lead a team of process engineers; develop and manage process validation strategies in compliance with cGMP; collaborate cross-functionally with R&D, Quality Assurance, Manufacturing Operations, and Regulatory Affairs; conduct root cause analysis for process deviations and implement CAPAs; evaluate and implement new technologies and equipment to improve process capabilities and capacity; prepare and review process documentation including P&IDs, batch records, and SOPs; ensure safety, environmental, and regulatory requirements; manage project timelines, budgets, and resources.
Required Qualifications
- Bachelor's or Master's degree in Chemical Engineering
- Minimum of 3 - 7 years of progressive experience in process engineering within the pharmaceutical or biotechnology industry, with at least 3 years in a leadership or managerial role
- Extensive knowledge of cGMP, FDA, EMA, and other relevant regulatory guidelines
- Proven track record of successful process development, optimization, and validation projects
- Strong understanding of unit operations in pharmaceutical manufacturing (e.g., mixing, filtration, purification, lyophilization, tablet compression)
- Experience with process analytical technology (PAT) and statistical process control (SPC)
- Excellent analytical, problem-solving, and decision-making skills
- Exceptional leadership, communication, and interpersonal skills with the ability to influence and collaborate effectively at all levels
- Proficiency in process simulation software and data analysis tools is a plus
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