Manufacturing Engineer II (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.
Essential Duties & Responsibilities
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.
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.
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.
Aid in evaluating and implementing new technologies, process automation, analytics, and equipment enhancements to support commercial operation.
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.
As a subject matter resource for internal audits, regulatory inspections, and cross-functional technical discussions.
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, Are Proactive & Agile, Act Ethically, Constantly Improve, Are Accountable.
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
B Shift: 10%
D Shift: 15%
Benefits information: https://www.tolmar.com/careers/employee-benefits