Process Engineer

BioSpace; Indianapolis (IN); On-site; USD 64,000 - 168,000; Full time

Job summary

Join a leading healthcare company as a Process Engineer responsible for ensuring the reliable operation of equipment and business processes. You will play a crucial role in driving continuous improvement efforts and maintaining compliance, while collaborating with cross-functional teams. This mid-senior level position offers a comprehensive benefits package and competitive salary based on experience.

Qualifications

• 3+ years of experience as a process engineer, preferably in pharmaceuticals.
• Strong troubleshooting skills for equipment/processes.
• Experience with GMP processes like Change Management and Event Management.

Responsibilities

• Ensure safe working environment by following safety rules.
• Lead troubleshooting for complex equipment and operational issues.
• Implement corrective actions from CAPAs.

Skills

Troubleshooting

Scientific/Statistical Analysis

Communication

Education

Bachelor's Degree in Engineering

Tools

Excel

JMP

Job description

Join to apply for the Process Engineer role at BioSpace.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees work to discover and bring life-changing medicines to those in need, improve understanding and management of disease, and give back through philanthropy and volunteerism. We prioritize our work and put people first.

Position Brand Description

The Process Engineer is responsible for establishing and maintaining the reliable operation and qualified state of the equipment and business processes they support. They ensure equipment is in control, compliant, and capable of meeting customer needs, while driving continuous improvement efforts. The Engineer works as a subject matter expert with the cross-functional support team to meet safety, quality, and productivity goals.

This role supports the Indy Parenteral 105B Vial Filling Line.

Key Objectives/Deliverables

• Ensure a safe working environment by following safety rules and promoting safety culture.
• Participate in safety activities such as audits, JSA’s, hazard reviews, etc.
• Design and operate equipment safely within the area.
• Provide engineering expertise as a member of the process team.
• Develop technical knowledge of equipment and processes.
• Establish and monitor control systems to optimize equipment performance.
• Lead troubleshooting for complex equipment and operational issues.
• Use problem-solving techniques, including Root Cause Analysis.
• Respond to customer requests related to equipment.
• Communicate effectively with team members, operations, engineering, and maintenance personnel.
• Oversee Maintenance Tech/Engineering Tech support.
• Assess activities for impact on equipment qualification and use appropriate change control processes.
• Manage system/component classification and maintenance strategies.
• Implement corrective actions from CAPAs.
• Participate in equipment reviews and validation activities (IQ/OQ/PQ).
• Understand and improve equipment reliability.
• Coordinate with asset management to replicate improvements.
• Identify and drive equipment improvement projects.
• Compare performance data to identify opportunities.

Basic Requirements

• Bachelor's Degree in Engineering and 3+ years of experience as a process engineer, preferably in pharmaceuticals.

Additional Preferences

• Strong troubleshooting skills for equipment/processes.
• Ability to apply scientific/statistical analysis to manufacturing problems.
• Experience with root cause analysis.
• Knowledge of Parenteral equipment and aseptic filling operations.
• Experience with GMP processes like Change Management and Event Management.
• Commitment to safety and a safe work environment.
• Effective communication skills for a collaborative environment.
• Proficiency in software such as Excel and JMP.
• Ability to work independently, organize, and adapt to changing priorities.
• Engineering and/or maintenance experience.

Other Information

• 8-hour dayshift; extended hours during peak periods.
• Respond to off-hour emergencies as needed.
• Occasional travel for training, conferences, or projects.

Lilly is committed to workplace accommodations for individuals with disabilities. For assistance, complete the accommodation request form at https://careers.lilly.com/us/en/workplace-accommodation.

We are an EEO employer, valuing diversity and inclusion in the workplace.

Compensation varies based on education, experience, skills, and location. The salary range is $64,500 - $167,200, with potential bonuses and comprehensive benefits.

Additional Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job functions: Management and Manufacturing