<p>Job Title: Operations EngineerJob Description</p> <p>The Operations Engineer will work within a dynamic organization in the North America Operations team, focusing on the timely execution and delivery of sterile drug products. This role ensures the reliability and quality compliance of manufactured products and reports to the Director of Operations.</p> <p>Responsibilities</p> <ul> <li>Serve as the primary Operations contact to ensure product reliability and quality compliance. </li><li>Drive reliability improvements and lead investigations or reviews of deviations and out-of-specifications using root cause analysis tools. </li><li>Maintain and manage a list of reliability-related improvement efforts for operations and engineering. </li><li>Manage projects or initiatives specifically related to reliability improvements. </li><li>Author and review Change Control and Quality Documents involving product or process changes. </li><li>Ensure operational compliance with US and international regulatory agencies and guidelines such as FDA, EU, HC, TGA, PIC/S, USP, NRC, and cGMP. </li><li>Review validations for equipment, cleaning, and processes in the assigned area. </li><li>Prepare and participate in regulatory agency audits and internal audits. </li><li>Act as the QA contact for risk management activities, including FMEA's. </li><li>Investigate customer complaints and deviations to identify root causes and corrective actions within required timeframes. </li><li>Analyze and report batch data to ensure regulatory compliance and identify trends for improvement. </li><li>Develop, review, and revise SOPs, Batch Records, and other documents with appropriate change management. </li><li>Adapt quickly in a fast-paced dynamic environment. </li><li>Communicate effectively with diverse cross-functional teams. </li></ul> <p>Essential Skills</p> <ul> <li>Bachelor's degree in Life Sciences or Engineering. </li><li>3 or more years of relevant experience, with pharmaceutical experience preferred. </li><li>Experience investigating deviations using Quality Engineering Tools and Techniques. </li><li>Familiarity with US and international regulatory guidelines for test procedures, equipment, processes, and facility systems. </li><li>Working knowledge of cGMP guidelines in a controlled aseptic environment. </li><li>Experience with statistical tools and certification in Lean or Six Sigma preferred. </li><li>Strong project management and organizational skills. </li><li>Advanced skills with Microsoft Office, MS Project, and Visio. </li></ul> <p>Additional Skills & Qualifications</p> <ul> <li>Experience in engineering and operations within a pharmaceutical and GMP environment. </li><li>Proficiency in Six Sigma and project management methodologies. </li></ul> <p>Work Environment</p> <p>The position requires onsite work Monday through Friday from 8am to 4:30pm. After approximately four months, the role will transition to a rotating schedule that includes occasional weekend coverage, likely one weekend every 4-6 weeks.</p> <p>Job Type & Location</p> <p>This is a Permanent position based out of Noblesville, IN.</p> <p>Pay and Benefits</p> <p>The pay range for this position is $90000.00 - $96000.00/yr.</p> <ul> <li>health, dental, and vision benefits - 401 (K) matching - Paid Holidays and time off. </li></ul> <p>Workplace Type</p> <p>This is a fully onsite position in Noblesville,IN.</p> <p>Application Deadline</p> <p>This position is anticipated to close on Mar 7, 2026.</p> <p>About Actalent</p> <p>Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.</p> <p>The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.</p> <p>If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.</p>