Chief Aseptic Officer – Sterile Device Production | Indianapolis, IN

Are you a strategic and operational leader with deep expertise in aseptic manufacturing and sterile device production? We are seeking a Chief Aseptic Officer (CAO) to oversee and elevate the production of sterile medical devices in Indianapolis, IN. This is a high-impact leadership opportunity to shape the future of sterile manufacturing, ensure compliance with the highest quality standards, and drive innovation in a rapidly evolving industry. If you’re passionate about cleanroom excellence, regulatory precision, and operational efficiency, this role is for you.

Lead Sterile Device Operations at a Premier Facility in Indianapolis

A leading medical device manufacturer based in Indianapolis, IN is looking for a Chief Aseptic Officer to lead its sterile device production division. The ideal candidate brings a wealth of experience in aseptic processing, FDA/ISO regulatory compliance, and GMP operations. You will play a critical role in driving production excellence, implementing cutting-edge aseptic technologies, and leading high-performing teams in a mission-critical environment. Join us to make a meaningful impact on patient safety and product quality across the healthcare landscape.

Key Responsibilities of the Chief Aseptic Officer – Sterile Device Production

Strategic Oversight & Vision:
Develop and execute a strategic plan for aseptic and sterile device production aligned with regulatory standards and organizational goals. Drive continuous improvement, innovation, and long-term capability growth in sterile operations.

Aseptic Manufacturing Excellence:
Lead and oversee all aspects of aseptic production processes, including cleanroom operations, sterilization protocols, and contamination control. Ensure adherence to GMP, FDA, ISO, and other regulatory standards in all sterile environments.

Regulatory Compliance & Quality Assurance:
Maintain a culture of compliance and quality excellence by collaborating with QA/RA teams. Ensure robust validation, documentation, and inspection readiness. Champion audit preparedness and proactive risk mitigation strategies.

Operational Optimization:
Streamline production workflows, optimize throughput, and enhance equipment utilization. Implement lean manufacturing principles and best practices to drive efficiency, reduce waste, and maintain product integrity.

Cross-Functional Leadership:
Collaborate with R&D, Quality, Engineering, Supply Chain, and Executive Leadership to align production strategies with business goals. Translate technical requirements into scalable, compliant, and efficient operations.

Team Leadership & Development:
Build, mentor, and lead a high-performing aseptic production team. Promote a culture of accountability, continuous training, and technical expertise. Ensure staffing, performance management, and talent development align with organizational needs.

Facility & Environmental Control:
Ensure the highest standards of facility hygiene, environmental monitoring, and HVAC system performance. Oversee upgrades, maintenance, and infrastructure improvements to meet evolving production demands.

Risk Management & Incident Response:
Implement proactive risk assessment tools and incident response protocols. Monitor and resolve deviations, CAPAs, and non-conformances in collaboration with QA and operational teams.

Innovation & Technology Advancement:
Evaluate and integrate emerging aseptic technologies and automation solutions. Stay ahead of industry advancements to enhance product sterility, reduce manual intervention, and improve operational scalability.

Stakeholder Communication & Reporting:
Report key performance metrics, compliance updates, and strategic initiatives to senior executives and board members. Maintain transparency through data-driven decision-making and cross-functional alignment.

What the Client is Looking for in You

As the Chief Aseptic Officer – Sterile Device Production, the client seeks a results-oriented leader with deep expertise in aseptic manufacturing, sterile processing, and regulatory compliance. You should be a highly disciplined, process-driven executive who can lead cross-functional teams, enforce rigorous standards, and drive operational excellence in a high-stakes healthcare manufacturing environment.

Proven Expertise in Aseptic and Sterile Manufacturing

The client is looking for an industry veteran with extensive experience managing sterile manufacturing operations in a regulated environment. A strong track record in cleanroom operations, environmental monitoring, contamination control, and aseptic process validation is essential. Experience with FDA, ISO 13485, cGMP, and other regulatory frameworks is highly valued.

Strategic Operator with Technical Vision

You should possess a strong ability to align production goals with company strategy while driving technological advancements in aseptic processing. The ideal candidate will have experience in scaling sterile manufacturing operations, implementing automation, and introducing continuous improvement practices to support long-term growth and product quality.

Leadership in Quality-Driven Environments

The client values a leader who thrives in quality-centric environments and can foster a culture of precision, accountability, and excellence. You must be capable of managing large production teams, maintaining compliance, and swiftly addressing deviations or CAPAs to uphold patient safety and regulatory standards.

Regulatory Acumen and Audit Readiness

In this role, an in-depth understanding of regulatory expectations is critical. The client is seeking someone who is audit-ready at all times, with experience leading successful FDA, ISO, or internal audits. Strong skills in documentation, validation, and root cause analysis are key differentiators.

Process Optimization and Cost Control

You should bring demonstrated experience in optimizing production processes for efficiency, scalability, and cost-effectiveness—without compromising quality. The client seeks someone who can streamline operations, improve OEE (Overall Equipment Effectiveness), and apply lean or Six Sigma methodologies effectively.

Collaborative Leadership and Team Development

The client values a CAO who leads by example and builds a collaborative, high-performance culture. You must be able to attract, mentor, and retain skilled production and quality personnel, fostering ongoing training and operational discipline across teams.

Strong Communication and Stakeholder Engagement

The ability to communicate technical processes clearly to cross-functional stakeholders—including executives, regulators, and suppliers—is essential. The ideal candidate can synthesize data into actionable insights and maintain transparency in all reporting and decision-making processes.

Unwavering Commitment to Patient Safety and Compliance

Above all, the client seeks a leader who places patient safety, compliance, and product integrity at the forefront of every decision. A deep-rooted understanding of the impact sterile device manufacturing has on patient outcomes is critical to success in this role.

FAQs About the Role – Chief Aseptic Officer – Sterile Device Production

1. What are the key responsibilities of the Chief Aseptic Officer in this role?
As the Chief Aseptic Officer, you will lead all sterile device manufacturing operations, ensuring strict adherence to aseptic processing and regulatory compliance. You will oversee production efficiency, quality assurance, risk management, and cross-functional collaboration to maintain product sterility and patient safety. Driving continuous improvement and innovation in sterile manufacturing practices will also be central to your role.

2. What qualifications and experience are required for this position?
The ideal candidate should have extensive leadership experience in aseptic or sterile device manufacturing within a regulated healthcare environment. Expertise in FDA regulations, ISO 13485 standards, cGMP, and cleanroom operations is essential. Proven success in managing large sterile production teams, process validation, and quality systems is highly valued. A technical degree in life sciences, engineering, or related fields is preferred.

3. What leadership qualities are essential for this role?
The client seeks a disciplined and collaborative leader who fosters a culture of quality, accountability, and operational excellence. Strong decision-making skills, the ability to lead cross-functional teams, and excellent communication with stakeholders are critical. You should be proactive in problem-solving and committed to continuous training and development of your team.

4. What challenges can I expect in this role?
Challenges include maintaining uncompromising compliance with stringent regulatory standards, managing complex aseptic processes, and driving production efficiency without sacrificing quality. You will need to address contamination risks, respond to audits and inspections, and balance innovation with validated, risk-controlled operations.

5. What is the expected impact of the Chief Aseptic Officer on the company’s operations?
You will play a critical role in ensuring the reliability, sterility, and safety of medical devices produced, directly impacting patient outcomes and company reputation. Your leadership will drive operational excellence, regulatory readiness, and scalability of sterile manufacturing processes to support business growth.

6. What is the company’s culture and work environment like?
The company promotes a quality-driven, patient-focused culture emphasizing compliance, teamwork, and continuous improvement. You will work in a highly regulated, fast-paced environment where innovation and operational discipline go hand-in-hand to deliver life-saving products.

What Remuneration Can You Expect from This Job?

As the Chief Aseptic Officer for Sterile Device Production in Indianapolis, IN, you can expect a highly competitive compensation package tailored to attract top-level expertise in sterile manufacturing leadership. The remuneration typically includes:

1. Base Salary
The base salary for a Chief Aseptic Officer varies depending on company size, complexity of operations, and experience. For mid-to-large medical device manufacturers, the annual base salary generally ranges between $180,000 and $350,000, with larger corporations or global firms offering higher packages.

2. Performance-Based Bonuses
In addition to the base salary, performance-based bonuses are commonly awarded based on key metrics such as production efficiency, compliance adherence, quality assurance, and regulatory milestones. These bonuses may range from 15% to 50% of the base salary, depending on individual and company performance.

3. Equity & Long-Term Incentives
Many companies offer equity participation or long-term incentive plans to align your leadership impact with company success. Stock options, restricted stock units (RSUs), or profit-sharing plans may be part of the overall remuneration, providing significant long-term financial benefits.

4. Benefits & Executive Perks
A comprehensive benefits package often accompanies this role, including:

Health, dental, and vision insurance
Retirement savings plans with company contributions (e.g., 401(k))
Paid time off and wellness programs
Professional development support and industry conference attendance
Relocation assistance if applicable

5. Signing Bonuses & Relocation Assistance
Top candidates may be eligible for signing bonuses and relocation support to facilitate their transition into the role, which can range from $10,000 to $50,000 depending on company policies and candidate profile.

Total Compensation Potential

Considering salary, bonuses, equity, and benefits, total annual compensation for a Chief Aseptic Officer in sterile device manufacturing can range from $220,000 to $450,000 or more, particularly in leading or rapidly growing firms.

How to Apply

If you are a results-oriented and experienced leader in sterile device manufacturing with a strong background in aseptic processing, regulatory compliance, and operational excellence, we invite you to apply for the Chief Aseptic Officer – Sterile Device Production role in Indianapolis, IN. This is a rare opportunity to lead critical manufacturing operations that directly impact patient safety and company growth.

To apply, please submit your updated resume along with a cover letter outlining your experience in sterile production leadership, aseptic process control, quality systems management, and regulatory compliance. Be sure to highlight your success in driving manufacturing efficiency, ensuring product sterility, and fostering a culture of continuous improvement.

This role offers a high-impact career path where you will influence manufacturing strategy, ensure compliance with stringent regulations, and lead a dedicated team in a highly regulated industry. Apply today to advance your leadership career as Chief Aseptic Officer in Indianapolis, IN!

For more information or to explore similar executive opportunities in medical device manufacturing, please visit our Aseptic Manufacturing Executive Search – Medical Device Sector Page.

Job Category: Sterile Device Production

Job Type: Full Time

Job Location: Indianapolis

Chief Aseptic Officer – Sterile Device Production | Indianapolis, IN