Associate Director, Reliability Engineering

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines - which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN - We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER - We work as one, respecting each voice and tapping into our unique strengths across teams-so we can solve problems in new ways.

Make it RIGHT - We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT - We take pride in our day-to-day work, knowing the impact we make - taking on challenges big and small to improve patient health.

This role:

The Associate Director of Reliability Engineering is responsible for developing, leading, and continuously improving the site reliability program to maximize equipment uptime, shutdown RTS performance, asset performance, product quality, safety, and regulatory compliance within a pharmaceutical manufacturing environment. This role provides strategic leadership for reliability-centered maintenance (RCM), asset lifecycle management, predictive and preventive maintenance programs, and continuous improvement initiatives across manufacturing, utilities, facilities, laboratories, and packaging operations.

The Associate Director partners closely with Engineering, Manufacturing, Quality, Validation, Facilities, Supply Chain, and EHS teams to ensure reliable and compliant operation of GMP-regulated systems while supporting business objectives, production targets, and capital investment strategies.

The responsibilities:

Reliability Strategy & Leadership

• Develop and execute the site's Reliability Engineering strategy aligned with business and operational goals.
• Improve and optimize manufacturing building shutdown program and vertical RTS (return to service) performance.
• Lead reliability improvement initiatives for manufacturing equipment, process systems, utilities, and critical facilities.
• Establish reliability standards, policies, procedures, and best practices across the organization.
• Lead and communication reliability metrics data to site leadership.
• Serve as the subject matter expert for asset reliability and maintenance excellence.

Asset Reliability & Performance Management

• Develop and manage Reliability-Centered Maintenance (RCM) programs.
• Analyze equipment performance, failure trends, and maintenance effectiveness to improve reliability.
• Conduct root cause analysis (RCA), failure mode and effects analysis (FMEA), and risk assessments.
• Identify and implement solutions to reduce downtime and improve Overall Equipment Effectiveness (OEE).
• Establish asset criticality models and reliability KPIs.

Maintenance Excellence

• Partner with Maintenance and Operations teams to optimize preventive and predictive maintenance programs.
• Drive implementation and utilization of condition-based monitoring technologies, including:

o Vibration analysis

o Infrared thermography

o Oil analysis

o Ultrasound monitoring

o Motor circuit analysis

• Support maintenance planning, scheduling, and work management processes within CMMS platforms.
• Monitor maintenance performance metrics and identify continuous improvement opportunities.

Pharmaceutical Compliance & Quality

• Ensure reliability programs comply with cGMP, FDA, EMA, and applicable regulatory requirements.
• Support regulatory inspections, audits, and quality investigations.
• Collaborate with Quality Assurance and Validation teams to maintain validated states of equipment and systems.
• Participate in deviation investigations, CAPA development, and change control processes.
• Ensure data integrity, documentation accuracy, and adherence to quality standards.

Utilities, Facilities & Critical Systems

• Provide reliability oversight for critical GMP systems, including:

o HVAC

o Water for Injection (WFI)

o Clean Steam

o Compressed Air

o Building Management Systems (BMS)

• Support risk mitigation strategies for critical utility and facility assets.
• Lead initiatives to improve system availability and energy efficiency.

Capital Projects & Asset Lifecycle Management

• Support design reviews and reliability requirements for new capital projects.
• Ensure maintainability and reliability principles are incorporated into equipment design and procurement.
• Develop asset replacement and lifecycle management strategies.
• Participate in FAT, SAT, commissioning, qualification, and startup activities.

Data Analytics & Continuous Improvement

• Utilize reliability and maintenance data to drive decision-making.
• Develop dashboards and reports to monitor reliability performance.
• Lead Lean, Six Sigma, and operational excellence initiatives.
• Benchmark reliability performance against industry best practices.
• Drive digital transformation initiatives related to smart maintenance and Industry 4.0 technologies.

Required qualifications:

Education

• Bachelor's degree in Engineering (Mechanical, Chemical, Electrical, Industrial, or related discipline) required.
• Master's degree in Engineering, Business Administration, or related field preferred.

Experience

• 10+ years of engineering, maintenance, or reliability experience within the pharmaceutical, biotechnology, medical device, or highly regulated manufacturing industries.
• 5+ years of leadership experience managing technical teams.
• Demonstrated success implementing reliability and maintenance excellence programs in GMP-regulated environments.
• Experience supporting FDA, EMA, and regulatory inspections.

Technical Knowledge

• Reliability-Centered Maintenance (RCM)
• Root Cause Analysis (RCA)
• FMEA and Risk-Based Maintenance
• CMMS systems (Maximo, D365, Blue Mountain, or similar)
• Predictive Maintenance technologies
• Asset Lifecycle Management
• OEE and Reliability Metrics
• GMP manufacturing operations
• Validation and Qualification processes
• Pharmaceutical utility systems

Preferred qualifications:

• Certified Reliability Engineer (CRE)
• Certified Maintenance & Reliability Professional (CMRP)
• Lean Six Sigma Green Belt or Black Belt
• Project Management Professional (PMP)

Physical / safety requirements:

• Ability to utilize required personal protective equipment (PPE)
• Dexterity and physical condition to perform some level of repetitive motion tasks
• Ability to stand or sit for extended periods of time

In return, you'll be eligible for[1]:

• Day One Benefits

• Medical & Dental Coverage

• Flexible Spending Accounts

• Life and AD&D Insurance

• Supplemental Life Insurance

• Spouse Life Insurance

• Child Life Insurance

• 401(k) Retirement Savings Plan with Company Match

• Time Off Program

• Paid Holidays

• Paid Time Off

• Paid Parental Leave and more

• Adoption Reimbursement Program

• Education Assistance Program

• Employee Assistance Program

• Community and Volunteer Service Program

• Employee Ownership Plan

• Additional Benefits

• Short and Long-Term Disability Insurance

• Voluntary Insurance Benefits

• Vision Coverage

• Accident

• Critical Illness

• Hospital Indemnity Insurance

• Identity Theft Protection

• Legal and more

• Onsite Campus Amenities

• Workout Facility

• Cafeteria

• Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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