PRIMARY PURPOSE:

The Senior Commercial Process Engineer – Compounding/Blending (Formulating) is responsible for the development, continuous improvement, optimization, and technical support of manufacturing processes for pharmaceutical products, ensuring compliance with current Good Manufacturing Practices (cGMP). Key responsibilities include the hands-on leading technology of transfers, troubleshooting deviations, performing process validations, and collaborating with cross-functional teams to enhance product quality, efficiency, and safety throughout the product lifecycle. This role will be an integral member of the team that develops and brings new products to market, as well as drive process improvement for current products.

MAJOR DUTIES AND RESPONSIBILITIES:

Process Improvement & Optimization:

Analyze commercial process monitoring data to identify trends, conduct technical investigations, and implement engineering solutions to improve yield, quality, and efficiency.

Technology Transfer:

Directly 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, biomedical engineering, or a related field.
Familiarity with compounding and processing liquids, creams, ointments, emulsions and aerosols.

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 GMP and other relevant pharmaceutical manufacturing regulations.

Problem-Solving:

Ability to conduct technical investigations and lead problem-solving initiatives to resolve complex manufacturing issues while operating within project completion deadlines.

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.
Black Belt Certification a plus

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.
Be able to explain technically complex theories to all levels of the organization effectively.
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 capable of detailed record keeping and communicating results to others.
Experience with pharmaceutical and consumer products related to creams, lotions, liquids, aerosols, nasal sprays, and/or gels is a plus.
Cleaning validation experience is strongly preferred.
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.
Lean Six Sigma Black Belt Preferred