_{13th October, 2025}

SUMMARY

With minimal supervision, support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions. Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems.

FUNCTIONS

• Applied Process Expertise
• Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
• Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities.
• Provide troubleshooting support.
• Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process

REQUIREMENTS

• Doctorate OR -Masters + 2 years of Manufacturing Operations experience OR Bachelors + 4 years of Manufacturing Operations experience OR Associates + 8 years of Manufacturing Operations experience OR High school/GED + 10 years of Manufacturing Operations experience.
• Academic background in Engineering disciplines, particularly Life Sciences, Engineering, Biotechnology, Chemistry, or a related technical discipline
• Engineering Experience in Manufacturing Operations 
• Hands-on experience in process engineering, manufacturing support, or production systems within a regulated environment (biotech, pharmaceutical, or similar).
• Technical Knowledge - Familiarity with automation systems, process equipment, and continuous improvement methodologies (Lean Six Sigma, Kaizen, root cause analysis).
• Problem-Solving Skills - Demonstrated ability to troubleshoot manufacturing issues, implement corrective/preventive actions (CAPA), and drive process optimization.
• Cross-Functional Collaboration - Proven experience working with operations, quality, and maintenance teams to deliver results in a fast-paced environment.
• Regulatory / GMP Knowledge - Understanding of cGMP, compliance, and documentation practices for regulated industries.
• Additional Strengths - Strong communication, adaptability to change

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