Process Development Engineer II - Manufacturing; 1st Shift

Overview

Core Hours

Monday - Friday, 6:00 am - 2:30 pm

Purpose and Scope

This role provides critical onfloor technical leadership for aseptic manufacturing operations, ensuring robust, compliant, and efficient processes. The engineer serves as a primary technical resource during sterile operations
, monitoring critical process parameters, identifying and mitigating risks in real time, and driving a culture of rightfirsttime performance
. The position also leads technical investigations, authors high quality reports, and partners with Manufacturing, Quality, Engineering, and MS&T to implement sustainable process and quality improvements
.

OnFloor Technical Support

• Serve as the primary technical engineering resource on the manufacturing floor during aseptic bulking, cleaning, milling, and filling activities.
• Actively monitor and verify critical operational steps, environmental controls, and inprocess parameters to ensure compliance with cGMP and aseptic best practices.
• Provide realtime decision support for process deviations, equipment malfunctions, and unexpected process conditions.
• Support manufacturing execution by ensuring processes consistently run within defined control limits and established batch record requirements.

Technical Investigations & Documentation

• Lead or support complex root cause investigations, deviations, CAPAs, and change controls; write clear, technically sound, inspection-ready reports.
• Use appropriate and approved tools to gather data and drive scientifically justified conclusions.
• Develop, revise, and optimize SOPs, Wis, batch records, and control documentation to strengthen process robustness and clarity.

Process Monitoring, Validation & Improvement

• Conduct and support onfloor studies and process verifications.
• Support cleaning validation, process validation, and ongoing process capability monitoring.
• Partner with Quality, Validation, and Engineering to ensure process changes and enhancements are technically justified and compliant.
• Lead and contribute to continuous improvement initiatives that improve yield, reduce variability, strengthen aseptic behaviors, and enhance equipment reliability.
• Assist in evaluating and implementing new technologies, process automation, analytics, and equipment enhancements to support commercial operation.

Training & Cross Functional Support

• Provide hands-on training, technical coaching, and aseptic technique reinforcement for operators and supervisors.
• Support onboarding of new operators and engineers with a focus on sterile technique, process understanding, and technical problem-solving.
• Act as a subject matter resource for internal audits, regulatory inspections, and cross functional technical discussions.

Other Duties

• Participate in hazardous waste, chemical handling, and spill response training; ensure compliance with all safety requirements.
• Perform additional responsibilities as assigned.

Knowledge, Skills & Abilities

• Strong knowledge of aseptic processing
  , sterile technique requirements, and pharmaceutical manufacturing systems.
• Demonstrated ability to monitor and troubleshoot aseptic operations and process performance issues.
• Strong analytical and problem-solving skills, including use of statistical tools and experimental design.
• Excellent technical writing skills; able to produce clear, concise, and scientifically sound investigations and reports
• Effective communicator with the ability to collaborate across manufacturing, quality, engineering, and development teams.
• High attention to detail, strong sense of personal accountability, and ability to excel in a fast-paced environment with shifting priorities.
• Ability to work independently with minimal oversight and make sound technical decisions in real time.
• Ability to analyze complex development problems and provide creative solutions.
• Strong analytical and problem-solving skills, including use of statistical and experimental tools.

Core Values

The Manufacturing Engineer II is expected to operate within the framework of Tolmar's Core Values:

• Center on People: We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together.
• Are Proactive & Agile: We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.
• Act Ethically: We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace.
• Constantly Improve: We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.
• Are…