MS AND T SENIOR PROCESS ENGINEER na None

PRIMARY PURPOSE: 

The MS&T (Manufacturing Science and Technology) Senior Process Engineer is responsible for the continuous improvement, optimization, and technical support of manufacturing processes for pharmaceutical products, ensuring compliance with Good Manufacturing Practices (GMP). Key responsibilities include leading technology transfers, troubleshooting deviations, performing process validations, and collaborating with cross-functional teams to enhance product quality, efficiency, and safety throughout the product lifecycle.  

MAJOR DUTIES AND RESPONSIBILITIES: 

Process Improvement & Optimization: 

• Analyze commercial process monitoring data to identify trends, conduct technical investigations, assess process robustness, identify critical processing parameters, and implement engineering solutions to improve product yield, quality, and efficiency. 

Technology Transfer: 

• Lead or support the transfer of new products and processes from R&D or other sites to commercial manufacturing, including conducting gap analyses and risk assessments. 

Validation & Documentation: 

• Author and execute validation protocols for process validation, cleaning validation, and equipment qualification. Develop and maintain essential technical documentation, including user requirements, SOPs, and reports. 

Troubleshooting & Deviation Management: 

• Investigate technical issues, lead Root Cause Analyses, and support the implementation of corrective and preventative actions (CAPAs) for deviations. 

Cross-Functional Collaboration: 

• Work with Quality, Manufacturing, R&D, and Project Management teams to achieve project objectives and ensure successful process implementation. 

Compliance & Regulatory Support: 

• Ensure all manufacturing activities adhere to regulatory requirements and GMP standards. Participate in internal and external audits and inspections. 

Equipment & Engineering Support: 

• Define user requirements for new process equipment and participate in Factory/Site Acceptance Testing (FAT/SAT) and commissioning for new systems. 

QUALIFICATION: 

Engineering Expertise: 

• A degree in chemical engineering or a related field. 

Technical Skills: 

• Proficient in statistical tools (e.g., JMP, Minitab) and data analysis, with strong technical writing and presentation skills. 

Regulatory Knowledge: 

• Thorough understanding of and other relevant pharmaceutical manufacturing regulations. 

Problem-Solving: 

• Ability to conduct technical investigations and lead problem-solving initiatives to resolve complex manufacturing issues. 

Communication & Collaboration: 

• Strong communication, interpersonal, and collaboration skills to work effectively in cross-functional teams. 

Lean/Six Sigma: 

• Familiarity with Lean or Six Sigma methodologies for driving continuous improvement. 

CRITICAL SKILLS AND ABILITIES: 

• Demonstrated ability for independent work, thought, and analysis.
• Ability to coordinate with internal groups as needed to achieve desired goals and deliverables (Manufacturing, Engineering, Supply chain, QA, QC, R&D, Project Management, etc.).
• Exceptional time management and multi-tasking skills.
• Excellent written and verbal communication skills with expertise in good documentation practices.
• Ability to perform statistical analysis of data and interpretation of data.
• Must be able to work extended hours on evenings and weekends as required.
• Must be capable of detailed record keeping and communicating results to others.
• At least 5 years experience with pharmaceutical and consumer products related to creams, lotions, liquids, aerosols, nasal sprays, and/or gels is a plus.
• Process validation experience is strongly preferred.

Education and/or Training  

• Proficient with Microsoft Office 365, including Teams, Word, Excel, and PowerPoint. 
• Minitab experience is preferred but not required. 

PHYSICAL DEMANDS 

• Must be able to lift and maneuver forty pounds. 
• Must be capable of standing for extended periods of time. 
• Must be able to wear personal protection equipment which includes gloves and respirator when required. 
• Ability to perform work in a manufacturing environment where there is exposure to occupational hazards. 
• Must be able to work extended hours on evenings and weekends as required.