Available ShiftsB Shift: Sunday - Wednesday, 5:00 pm - 5:30 am, every other Wednesday off
D Shift: Wednesday - Saturday, 5:00 pm - 5:30 am, every other Wednesday off
Purpose and ScopeThis 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.
Essential Duties & ResponsibilitiesOn-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.
Education & Experience- Bachelor's degree in Chemical engineering or other scientific discipline required.
- Three or more years of experience in pharmaceutical/biotech process development, manufacturing, or MS&T support role.
- Two or more years of experience in aseptic operations.
Working Conditions- Work occurs in office and manufacturing environments.
- Requires on-floor presence during critical production activities.
- Occasional weekend or evening support may be required based on manufacturing needs.
- May require lifting up to 25 lbs. and respirator use.
Compensation and Benefits- Annual pay range $88,000 - $95,000 depending on experience
- Bonus Eligible
- Shift Differential
- B Shift: 10%
- D Shift: 15%
- Benefits information: https://www.tolmar.com/careers/employee-benefits
Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.
