Process Development Engineer II - Manufacturing; 1st, 2nd or 3rd Shift

Purpose and Scope

This role provides critical on‑floor 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 right‑first‑time 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
.

On‑Floor 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 in‑process parameters to ensure compliance with cGMP and aseptic best practices.
• Provide real‑time 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 on‑floor 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 Process Development Engineer - Manufacturing 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…