Director of Process Engineering & Transformation

Harba Solutions Inc.; Indiana; On-site; USD 150,000 - 190,000; Full time

Job summary

Harba Solutions Inc. seeks a Director of Process Engineering to oversee key site engineering functions including process engineering, product commercialization, capital delivery, process reliability, controls engineering, and project management.

You will lead a cross-functional team to advance engineering excellence while ensuring regulatory compliance. Responsibilities include developing PQA/validation plans, coordinating with Regulatory, managing process documentation, and driving safety and

Qualifications

• Bachelor’s degree in Engineering or related field.
• 15+ years of engineering experience in pharma.
• 10+ years in engineering leadership.

Responsibilities

• Coach and develop process engineering team members and managers.
• Lead transfer and commercialization of new products and processes.
• Manage Process Performance Qualification and Validation activities.
• Partner with Regulatory for process/product content for submissions.
• Own site Process Control Strategies and FMEAs.
• Develop and maintain production batch records and process documentation.
• Oversee process equipment and automation with Validation.
• Plan capital, project management, and delivery of process equipment.
• Develop and trend process metrics and in-process controls.
• Lead process reliability activities and data analysis for Product Reviews.
• Oversee nonconformances, CAPAs, change controls, and complaints.
• Work with Maintenance for spare-parts and calibration programs.
• Collaborate with Procurement on relationships with equipment manufacturers.
• Lead technical writing supporting site initiatives.
• Promote safety, compliance, continuous improvement, and development.

Skills

Leadership

Cross-functional collaboration

Process engineering

Regulatory compliance

Project management

Technical writing

Performance analysis

Education

Bachelor’s degree in Engineering or related field

Job description

Harba Solutions Inc. seeks a Director of Process Engineering to oversee key site engineering functions including process engineering, product commercialization, capital delivery, process reliability, controls engineering, and project management.

You will lead a cross-functional team to advance engineering excellence while ensuring regulatory compliance. Responsibilities include developing PQA/validation plans, coordinating with Regulatory, managing process documentation, and driving safety and