Director of Process Engineering

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

The Director of Process Engineering oversees key pharmaceutical site engineering functions, including process engineering, product commercialization, capital and project delivery, process reliability, controls engineering, and project management. This role leads a team of technical professionals and partners cross-functionally to advance process engineering excellence while maintaining compliance with applicable regulatory standards and guidance.

Job Requirements

• Coach and develop process engineering team members and managers, conduct performance reviews, and establish objectives and performance measures.
• Lead the transfer and commercialization of new products and processes.
• Manage Process Performance Qualification and Validation Master Plan activities, including protocol development, execution, and final reporting.
• Partner with Regulatory to develop process and product content for new product submissions.
• Own site Process Control Strategies and Process FMEAs.
• Lead the development and maintenance of production batch records, process documentation, procedures, job aids, forms, training materials, and qualification documentation.
• Oversee process equipment and automation activities in partnership with Validation.
• Manage the specification, capital planning, project management, and delivery of process equipment across the site.
• Develop, maintain, and trend process metrics, including critical and key process parameters, in-process controls, yields, and finished-product release results.
• Lead process reliability activities, including issue prioritization, resolution, equipment metrics, and data analysis for periodic Product Reviews.
• Oversee process-related nonconformances, CAPAs, change controls, and complaints.
• Partner with Maintenance to establish effective spare-parts, preventive-maintenance, and calibration programs.
• Partner with Procurement to manage relationships with key equipment manufacturers.
• Lead technical writing activities supporting site initiatives.
• Promote safety, compliance, continuous improvement, and strong technical development within Engineering.
• Recruit and develop engineering talent while building effective cross-functional relationships.
• Maintain operational compliance with US and international regulatory requirements.

Job Qualifications

• Bachelor’s degree in Engineering or a related field required; advanced degree preferred.
• 15+ years of engineering experience within the pharmaceutical industry.
• 10+ years of engineering leadership experience.