New River Community College
Process Engineer/ Senior Process Engineer, Medicines for All Institute
New River Community College, Richmond, Virginia, United States, 23214
Job Summary
Medicines for All (M4ALL), 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 M4ALL'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 M4ALL 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 problem‑solving and troubleshooting skills.
Excellent communication and interpersonal skills.
Strong organizational skills and attention to detail; able to balance multiple priorities.
Ability to work effectively in a fast‑paced, collaborative environment.
Demonstrated ability to use good judgment and decision making, responding calmly and effectively in crisis situations.
Unwavering commitment to aligning and adhering to M4ALL's core values and purpose.
Exhibit high ethical standards and promote respectful behavior within the organization.
Demonstrated ability to work in and foster an environment of respect, professionalism and civility with a population of faculty, staff, and students from all backgrounds and experiences, or a commitment to do so as a staff member at VCU.
Must be able to provide own transportation to travel occasionally between multiple worksites during the initial phases of the project.
Possess a mindset to thrive in a dynamic, start‑up‑like environment, with the flexibility to work differing hours on occasion.
Experience authoring or reviewing technical documents for regulatory submissions (CTD modules, validation reports, etc.).
Proven ability to communicate technical concepts clearly to both scientific and non‑technical audiences.
Enthusiasm for identifying and implementing process optimization and sustainability initiatives.
Demonstrated creativity in solving complex technical or operational problems.
Self‑starter with a proactive mindset and commitment to maintaining safety, compliance, and quality standards at all times.
Preferred Qualifications
Exposure to process safety assessment tools (e.g., thermal screening, reaction calorimetry).
Exposure to Quality by Design (QbD) and statistical tools.
Experience working in a contract manufacturing organization (CMO) or contract development & manufacturing organization (CDMO), in a multi‑purpose manufacturing environment.
Title Distinction This job posting welcomes candidates with diverse levels of experience. We will consider hiring at either the Process Engineer or Senior Process Engineer level based on the selected candidate's qualifications and experience. The Senior Process Engineer level will be distinguished by advanced experience in process development, technology transfer and pharmaceutical manufacturing.
Reporting Structure This role reports to Associate Director - Manufacturing, Science & Technology and embodies everyday leadership, with an expectation to lead through actions, discussions, decisions, and interactions. As a role model within the organization, you will influence others by consistently demonstrating the values and behaviors that drive our mission forward.
Work Environment Upon hire, the workstation will be based at the VA Bio+Tech Park and will transition to the Chesterfield, VA location once facility is ready for occupancy.
Travel Travel (≤10%) may be required and occasional shift work as needed.
Additional Details Salary Range Salary will be commensurate based on selected candidate's background. Process Engineer: $75,000 – $105,000; Senior Process Engineer: $90,000 – $125,000
Benefits All full‑time university staff are eligible for VCU's robust benefits package that includes comprehensive health benefits, paid annual and holiday leave granted up front, generous tuition benefits, retirement planning and savings options, tax‑deferred annuity and cash match programs, employee discounts, well‑being resources, abundant opportunities for career development and advancement, and more.
FLSA Exemption Status Exempt
Hours per Week Minimum 40 hours/week; Monday - Friday (Primarily day shift with occasional shift work)
Restricted Position Yes
ORP Eligible No
Flexible Work Arrangement On‑site Requirement
Eligible for Sponsorship (e.g. H‑IB visa status, etc.) No
Contact Information M4all@vcu.edu
Unit Medicines for All Institute, Office of the Senior Vice President for Health Sciences
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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 M4ALL'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 M4ALL 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 problem‑solving and troubleshooting skills.
Excellent communication and interpersonal skills.
Strong organizational skills and attention to detail; able to balance multiple priorities.
Ability to work effectively in a fast‑paced, collaborative environment.
Demonstrated ability to use good judgment and decision making, responding calmly and effectively in crisis situations.
Unwavering commitment to aligning and adhering to M4ALL's core values and purpose.
Exhibit high ethical standards and promote respectful behavior within the organization.
Demonstrated ability to work in and foster an environment of respect, professionalism and civility with a population of faculty, staff, and students from all backgrounds and experiences, or a commitment to do so as a staff member at VCU.
Must be able to provide own transportation to travel occasionally between multiple worksites during the initial phases of the project.
Possess a mindset to thrive in a dynamic, start‑up‑like environment, with the flexibility to work differing hours on occasion.
Experience authoring or reviewing technical documents for regulatory submissions (CTD modules, validation reports, etc.).
Proven ability to communicate technical concepts clearly to both scientific and non‑technical audiences.
Enthusiasm for identifying and implementing process optimization and sustainability initiatives.
Demonstrated creativity in solving complex technical or operational problems.
Self‑starter with a proactive mindset and commitment to maintaining safety, compliance, and quality standards at all times.
Preferred Qualifications
Exposure to process safety assessment tools (e.g., thermal screening, reaction calorimetry).
Exposure to Quality by Design (QbD) and statistical tools.
Experience working in a contract manufacturing organization (CMO) or contract development & manufacturing organization (CDMO), in a multi‑purpose manufacturing environment.
Title Distinction This job posting welcomes candidates with diverse levels of experience. We will consider hiring at either the Process Engineer or Senior Process Engineer level based on the selected candidate's qualifications and experience. The Senior Process Engineer level will be distinguished by advanced experience in process development, technology transfer and pharmaceutical manufacturing.
Reporting Structure This role reports to Associate Director - Manufacturing, Science & Technology and embodies everyday leadership, with an expectation to lead through actions, discussions, decisions, and interactions. As a role model within the organization, you will influence others by consistently demonstrating the values and behaviors that drive our mission forward.
Work Environment Upon hire, the workstation will be based at the VA Bio+Tech Park and will transition to the Chesterfield, VA location once facility is ready for occupancy.
Travel Travel (≤10%) may be required and occasional shift work as needed.
Additional Details Salary Range Salary will be commensurate based on selected candidate's background. Process Engineer: $75,000 – $105,000; Senior Process Engineer: $90,000 – $125,000
Benefits All full‑time university staff are eligible for VCU's robust benefits package that includes comprehensive health benefits, paid annual and holiday leave granted up front, generous tuition benefits, retirement planning and savings options, tax‑deferred annuity and cash match programs, employee discounts, well‑being resources, abundant opportunities for career development and advancement, and more.
FLSA Exemption Status Exempt
Hours per Week Minimum 40 hours/week; Monday - Friday (Primarily day shift with occasional shift work)
Restricted Position Yes
ORP Eligible No
Flexible Work Arrangement On‑site Requirement
Eligible for Sponsorship (e.g. H‑IB visa status, etc.) No
Contact Information M4all@vcu.edu
Unit Medicines for All Institute, Office of the Senior Vice President for Health Sciences
#J-18808-Ljbffr