EM/GMP Process Professional II

About the role

The EM/GMP Process Professional II supports operations in aseptic production, solid dosage forms, fill & finish warehousing, and quality control. They collaborate with stakeholders and provide training to lower-level peers. Essential functions include conducting deviation investigations, implementing process improvements, and managing area content and process knowledge.

Responsibilities

• Drive continuous improvements using Lean tools and Six Sigma methodologies
• Support training for lower-level team members
• Provide process solutions for moderate to high complexity issues
• Contribute through application of expertise and knowledge
• Follow safety and environmental requirements

Requirements

• Bachelor’s degree in engineering, technology, or related field from an accredited university preferred
• Four years of manufacturing experience in a pharmaceutical environment, preferably in a GMP setting
• Two years of manufacturing experience in a pharmaceutical environment, preferably in a GMP setting
• Excellent written communication skills
• Systematic problem-solving experience
• Lean manufacturing experience and training
• General knowledge of change control systems and Quality Management Systems (QMS)
• Relevant electronic manufacturing system experience (e.g., SAP, PAS-X, etc.)
• Demonstrated knowledge of adult learning methodologies and ability to train and coach others
• General experience with regulatory audits/inspections
• Knowledge of relevant master data
• Validation experience
• Product transfer (or tech transfer) experience a plus

Qualifications

• High School Diploma (GED) with a minimum of six years of manufacturing experience required, preferably in a pharmaceutical manufacturing environment
• Two years of manufacturing experience required, preferably in a pharmaceutical manufacturing environment
• Excellent written communication skills
• Systematic problem-solving experience
• Lean manufacturing experience and training
• General knowledge of change control systems and Quality Management Systems (QMS)
• Relevant electronic manufacturing system experience (e.g., SAP, PAS-X, etc.)
• Demonstrated knowledge of adult learning methodologies and ability to train and coach others
• General experience with regulatory audits/inspections
• Knowledge of relevant master data
• Validation experience
• Product transfer (or tech transfer) experience a plus