Manufacturing Engineer II

Responsibilities

• Provide on-floor technical leadership for aseptic manufacturing operations, including bulking, cleaning, milling, and filling.
• Monitor critical process parameters and environmental controls to ensure compliance with cGMP and aseptic best practices.
• Lead technical investigations, including root cause analysis for deviations, CAPAs, and change controls.
• Author high-quality, inspection-ready technical reports, SOPs, and batch records.
• Support process validation, cleaning validation, and continuous improvement initiatives to enhance yield and reliability.
• Provide hands-on training and technical coaching to operators and supervisors regarding sterile techniques.

Requirements

• Bachelor's degree in Chemical Engineering or a related scientific discipline.
• 3+ years of experience in pharmaceutical or biotech manufacturing, process development, or MS&T.
• 2+ years of direct experience in aseptic operations.
• Strong knowledge of sterile techniques and aseptic processing requirements.
• Excellent technical writing skills with the ability to produce scientifically sound documentation.
• Strong analytical and problem-solving skills, including familiarity with statistical tools.

Benefits

• Annual pay range of $88,000 - $95,000 depending on experience.
• Bonus eligibility.
• Comprehensive benefits package.

About the Company

Tolmar is a pharmaceutical company dedicated to improving patient lives through high-quality products and ethical business practices. We foster a culture of proactive engagement, continuous improvement, and accountability.