Process Engineer​/Senior Process Engineer, Medicines Institute

Position: Process Engineer/ Senior Process Engineer, Medicines for All Institute

Job Summary

Medicines for All (M4

ALL), a part of Virginia Commonwealth University, is an entrepreneurial, impact-oriented institute dedicated to dramatically improving global access to lifesaving medicines. We achieve this through synthetic process innovation and advanced technology deployment to reduce costs and waste in small molecule drug substance manufacturing. Our work supports treatments for diseases such as TB, malaria, HIV, oncology, metabolic diseases, CNS, and immunology.

We are seeking a Process Engineer/ Senior Process Engineer with Active Pharmaceutical Ingredient (API) process development and manufacturing experience to contribute to the design and start‑up of a cGMP API kilo‑scale facility. The role will support scale‑up, optimization, and technology transfer of API processes. The successful candidate will work closely with cross‑functional colleagues to support the overall site goals. Ideal candidates should have Good Manufacturing Practice understanding and experience, and demonstrate technical ability, scientific creativity, teamwork and communication skills.

Primary

Responsibilities Safety and Compliance

• Ensure all operations are conducted with a Safety-First mindset, adhering to OSHA and environmental regulations.
• Maintain compliance with current Good Manufacturing Practices (cGMP) and internal quality systems.
• Champion M4
  
  ALL's culture of safety, integrity, and operational excellence.

Equipment and Process Validation

• Support or lead activities related to equipment qualification (IQ/OQ) and process validation.
• Author, review, and execute validation protocols and reports in compliance with cGMP standards.
• Collaborate with cross‑functional stakeholders to ensure validated systems are ready for use.

Technical Documentation

• Prepare and review critical technical documents including:
  • User Requirements Specifications (URS)
  • Functional Requirement Specifications (FRS)
  • Batch Records, Cleaning Records, and Process Descriptions
  • Risk Analyses / Assessments, Process Mass Balances, and Technology Transfer Reports
  • Standard Operating Procedures (SOPs)
• Ensure documentation accurately reflects process understanding and supports regulatory readiness.

Process Development and Scale‑Up

• Collaborate with internal R&D and external partners to develop and scale‑up API manufacturing processes from laboratory to kilo‑scale.
• Apply chemical engineering principles to ensure process robustness, scalability, and reproducibility.
• Support process hazard assessments and define engineering controls for safe operation.

Technology Transfer

• Lead or support incoming technology transfers from M4
  
  ALL R&D and external partners and outgoing transfers to manufacturing partners.
• Translate process knowledge into practical, operational documentation and training.
• Ensure “right‑first‑time” implementation of transferred processes.

Process Optimization and Continuous Improvement

• Identify and implement opportunities to improve yield, throughput, cycle time, and cost efficiency while maintaining product quality and regulatory compliance.
• Utilize data‑driven approaches and process analytics to enhance manufacturing performance.
• Collaborate with internal teams to implement corrective and preventive actions (CAPA).

Troubleshooting and Technical Support

• Provide on‑the‑floor technical support during manufacturing campaigns.
• Investigate and resolve process deviations, batch failures, and equipment malfunctions.
• Partner with appropriate teams to ensure timely and effective resolution of production issues.

Data Analysis and Reporting

• Analyze process and product data to monitor performance trends and drive continuous improvement initiatives.
• Support generation of technical reports, presentations, and updates for internal and external stakeholders.

Qualifications

Required Qualifications

• Education
  :
  Bachelor's Degree in Chemical Engineering, Pharmaceutical Engineering; or the experience and skills that equate to a degree.
• Experience
  :
  Minimum of 5 years of experience in the pharmaceutical industry with a focus on API process development, scale‑up or commercial manufacturing.
• Strong knowledge of regulatory requirements and guidelines (e.g., FDA, EMA, ICH).
• Excellent…