Senior Process Manufacturing Engineer

Join our team in St. Louis, MO as a Senior Process Manufacturing Engineer and play a key role in establishing manufacturing process capability for new and reformulated products. This onsite position operates Monday through Friday during core business hours.

Responsibilities

• Support the execution of protocols to comply with FDA and cGMP requirements for equipment qualification, cleaning, and process validations.
• Develop and promote a lean culture, instituting lean principles throughout manufacturing processes.
• Create plans, design experiments, and schedules for establishing manufacturing process capability and introducing new or reformulated products.
• Interface with Product Development and Production teams to transition processes from research laboratories through scale-up to full-scale manufacturing.
• Research and test new technologies or processes to support new and existing product manufacturing.
• Establish and maintain set point controls for manufacturing processes.
• Support Project Engineering in obtaining approval for Capital Appropriation Requests, design specifications, and equipment installation.
• Provide training, develop manufacturing instructions, and assist in the start-up of new processes and equipment.
• Conduct process studies, identify improvement opportunities, and implement findings to optimize liquid blending systems.
• Resolve manufacturing deficiencies through troubleshooting and corrective actions.
• Develop and submit detailed written reports, including objectives, experimental data, engineering analysis, conclusions, and recommendations.
• Monitor and address issues related to quality, yields, throughput, cycle times, process parameters, cGMP compliance, safety, and environmental requirements.
• Apply structured problem-solving methodologies (e.g., DMAIC, Six Sigma) to confirm root causes of problems.
• Implement corrective and preventive actions to reduce variation and drive improvements in quality and other key KPIs.
• Serve as a Subject Matter Expert (SME) with deep technical insights into operations processes, including chemical and biological formulation, filling, packaging, and quality operations.
• Employ project management principles, including establishing timelines, identifying risks, and communicating across teams at all levels.
• Develop P&IDs in support of validation efforts and design experiments (DOE) for scale-up, troubleshooting, and process modifications.
• Provide indirect supervision of technicians, interns, and operators as required.

Requirements

• Bachelor’s degree in Engineering (preferably biochemical, chemical, or microbiology).
• Minimum of five (5) years of experience in process engineering or an equivalent field.
• Experience with FDA and GMP-regulated operations, such as medical devices or pharmaceutical manufacturing.
• Strong project leadership, technical, and organizational skills.
• Proven ability to facilitate problem-solving and team-based root cause analysis (RCA).
• Ability to generate detailed, high-quality technical documentation.
• Strong communication and interpersonal skills, with the ability to influence team performance.

Preferred Qualifications

• Lean Six Sigma certification (Green Belt or Black Belt).

Benefits

• Market-competitive pay with a range of $92,650.00 - $119,900.00, plus bonus eligibility.
• Extensive paid time off and additional holidays.
• Comprehensive healthcare, dental, and vision benefits.
• Long- and short-term disability coverage.
• 401(k) with company match.
• Maternity and paternity leave.
• Pet insurance and other add-on benefits/discounts.
• Tuition reimbursement and continuing education programs.
• Opportunities for career advancement in a stable, long-term environment.