Executive - Process Engineering

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Piramal Pharma Solutions

Piramal Pharma Solutions is a contract development and manufacturing  organization (CDMO), offering end-to-end development and manufacturing  solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.  

This enables us to offer a comprehensive range of services including Drug Discovery  Solutions, Process & Pharmaceutical Development services, Clinical Trial  Supplies, Commercial supply of APIs and Finished dosage forms. We also offer  specialized services like development and manufacture of Highly Potent APIs  and Antibody Drug Conjugation.  

Our capability as an integrated service provider  & experience with various technologies enables us to serve Innovator and  Generic companies worldwide.  

For more details, please visit : www.piramalpharmasolutions.com

Job Title

Executive - Process Engineering

Job Description

Executive - Process Engineering

Job Summary**

PPL Pharma Inc. is seeking an Executive - Process Engineering to lead and optimize manufacturing processes, ensuring efficiency, quality, and compliance within our pharmaceutical production facilities. This role will drive continuous improvement initiatives and technological advancements.

Job Responsibilities**

* Oversee the design, development, and optimization of pharmaceutical manufacturing processes from concept to commercialization.
* Lead a team of process engineers, providing technical guidance, mentorship, and performance management.
* Identify and implement process improvements to enhance yield, reduce costs, increase efficiency, and ensure product quality.
* Develop and manage process validation strategies and protocols in compliance with cGMP regulations and industry standards.
* Collaborate cross-functionally with R&D, Quality Assurance, Manufacturing Operations, and Regulatory Affairs to ensure seamless process integration and product transfer.
* Conduct root cause analysis for process deviations and implement effective corrective and preventive actions (CAPAs).
* Evaluate and implement new technologies and equipment to improve process capabilities and capacity.
* Prepare and review technical documentation, including process flow diagrams, P&IDs, batch records, and standard operating procedures (SOPs).
* Ensure all process engineering activities adhere to safety, environmental, and regulatory requirements.
* Manage project timelines, budgets, and resources for process engineering initiatives.

Job 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 various 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.