Senior Continuous Improvement Engineer (Carmel)
Aegis Worldwide, Carmel, IN, United States
We are partnering with a pharmaceutical company in the Carmel, IN area to identify a
Senior Continuous Improvement Engineer
who will drive operational excellence across development, manufacturing, and quality/compliance functions within a highly regulated environment.
This individual will play a key role in improving efficiency, reducing variability, and strengthening processes while ensuring alignment with FDA and broader regulatory standards.
Direct-hire, full-time Compensation:
Base salary, annual bonus, and full benefits package starting day one. Hours:
Monday - Friday, 7-4, 8-5
Responsibilities: Lead and execute continuous improvement initiatives using Lean, Six Sigma, and structured problem-solving methodologies Partner with Development, Manufacturing, and Quality teams to identify process inefficiencies and implement sustainable solutions Facilitate root cause analyses, Kaizen events, and rapid improvement efforts to resolve critical issues and improve performance Step in to support high-priority or off-track projects, driving alignment and ensuring timely execution Utilize data analysis and statistical tools to identify trends, reduce variability, and improve decision-making Establish and track KPIs to monitor process performance and sustain improvements Develop and standardize processes, systems, and governance to support long-term operational success Ensure all initiatives are compliant with regulatory requirements, including FDA, cGMP, OSHA, and EPA standards
Requirements: Bachelor’s degree in Engineering or a related technical field 10+ years of relevant experience Experience in engineering roles related to continuous improvement, manufacturing, or operations within pharma, biotech, or medical device Experience supporting at least two of the following areas: new product development, technical transfer, manufacturing operations, supply chain operations, or compliance Strong working knowledge of regulatory and compliance requirements, including FDA, cGMP, OSHA, and EPA Proven success leading Lean and/or Six Sigma initiatives with measurable impact (Black Belt preferred) Demonstrated ability to lead cross-functional teams and influence stakeholders at multiple levels Experience with data analysis, statistical tools, and structured problem-solving approaches Strong project management skills with the ability to manage multiple priorities simultaneously Ability to operate effectively in fast-paced, high-pressure environments
Senior Continuous Improvement Engineer
who will drive operational excellence across development, manufacturing, and quality/compliance functions within a highly regulated environment.
This individual will play a key role in improving efficiency, reducing variability, and strengthening processes while ensuring alignment with FDA and broader regulatory standards.
Direct-hire, full-time Compensation:
Base salary, annual bonus, and full benefits package starting day one. Hours:
Monday - Friday, 7-4, 8-5
Responsibilities: Lead and execute continuous improvement initiatives using Lean, Six Sigma, and structured problem-solving methodologies Partner with Development, Manufacturing, and Quality teams to identify process inefficiencies and implement sustainable solutions Facilitate root cause analyses, Kaizen events, and rapid improvement efforts to resolve critical issues and improve performance Step in to support high-priority or off-track projects, driving alignment and ensuring timely execution Utilize data analysis and statistical tools to identify trends, reduce variability, and improve decision-making Establish and track KPIs to monitor process performance and sustain improvements Develop and standardize processes, systems, and governance to support long-term operational success Ensure all initiatives are compliant with regulatory requirements, including FDA, cGMP, OSHA, and EPA standards
Requirements: Bachelor’s degree in Engineering or a related technical field 10+ years of relevant experience Experience in engineering roles related to continuous improvement, manufacturing, or operations within pharma, biotech, or medical device Experience supporting at least two of the following areas: new product development, technical transfer, manufacturing operations, supply chain operations, or compliance Strong working knowledge of regulatory and compliance requirements, including FDA, cGMP, OSHA, and EPA Proven success leading Lean and/or Six Sigma initiatives with measurable impact (Black Belt preferred) Demonstrated ability to lead cross-functional teams and influence stakeholders at multiple levels Experience with data analysis, statistical tools, and structured problem-solving approaches Strong project management skills with the ability to manage multiple priorities simultaneously Ability to operate effectively in fast-paced, high-pressure environments