Sr. Process Engineer

Job Title: Sr. Process Engineer Location: Saint Louis, MO

Experience: 10+ years Employment Type: 12+ months Contract

Job Overview: We are seeking an experienced Senior Product Steward / Senior Process Engineer to lead the oversight and continuous improvement of commercial biopharmaceutical manufacturing processes. The ideal candidate will ensure that all processes are robust, validated, and compliant with regulatory standards throughout the product lifecycle. This role requires a deep understanding of process development, validation practices, and regulatory requirements in the biopharmaceutical industry, combined with strong analytical and problem-solving skills to drive efficiency and quality improvements.

Key Responsibilities:

Lead the oversight, monitoring, and continuous improvement of commercial biopharmaceutical manufacturing processes.

Ensure all processes are validated, robust, and meet regulatory compliance standards.

Collaborate with cross-functional teams, including Quality, Manufacturing, and Regulatory Affairs, to support product lifecycle management.

Apply process development and optimization techniques to improve efficiency, yield, and product quality.

Utilize process simulation and statistical modeling tools to analyze process performance and support decision-making.

Implement Lean Six Sigma methodologies to identify opportunities for process improvement and reduce variability.

Provide technical guidance and mentorship to junior engineers and team members.

Prepare and review technical documentation, including validation protocols, reports, and regulatory submissions.

Qualifications

• Bachelor’s or higher degree in Chemical Engineering, Biomedical Engineering, Biochemistry, or a related field.

• Minimum of 10 years of relevant experience in biopharmaceutical process engineering or manufacturing.

• Proven experience in process development, process validation, and regulatory compliance.

• Proficiency in process simulation and statistical modeling software.

• Strong knowledge of Lean Six Sigma principles and their application in manufacturing.

• Excellent analytical, problem-solving, and communication skills.