Process Engineer

Job Summary

We are seeking a highly motivated and detail-oriented Oral Solid Dosage (OSD) Process Engineer to join our pharmaceutical manufacturing team. In this role, you will support the design, implementation, optimization, and scale-up of oral solid dosage manufacturing processes with a focus on granulation, blending, compression, and packaging operations. You will collaborate with internal engineering teams, manufacturing, quality, and external Architecture & Engineering (A&E) firms to execute CAPEX projects, improve process performance, and ensure compliance with GMP, safety, and regulatory requirements. Experience with high-potency compounds, pharmaceutical process equipment, and continuous improvement initiatives is highly valued.

Duties

• Develop, optimize, and support Oral Solid Dosage (OSD) manufacturing processes, including granulation, mixing, blending, roller compaction, tablet manufacturing, and packaging operations.
• Lead and support CAPEX projects in collaboration with internal stakeholders and external Architecture & Engineering (A&E) firms, ensuring projects are delivered on time and within budget.
• Provide technical expertise for the installation, commissioning, qualification, and validation of pharmaceutical process equipment.
• Support deployment, startup, and optimization of Glatt high-shear mixers (e.g., VG-600) and Gerteis roller compactors (e.g., Macro-Pactor).
• Optimize granulation and mixing processes to improve product quality, process robustness, throughput, and manufacturing efficiency.
• Support process troubleshooting using structured root cause analysis (RCA) methodologies and implement effective corrective and preventive actions (CAPA).
• Collaborate with Manufacturing, Quality Assurance, Validation, Maintenance, and Engineering teams to ensure compliance with cGMP, FDA, and safety requirements.
• Develop and review process documentation, including SOPs, batch records, engineering specifications, URS, FAT/SAT protocols, IQ/OQ/PQ documentation, and change controls.
• Support implementation of equipment upgrades, process improvements, and automation initiatives to enhance operational performance.
• Provide technical oversight for potent compound processing, ensuring appropriate containment strategies, equipment selection, and EHS controls are implemented.
• Support downstream packaging systems, including bottle filling, blister packaging, labeling, serialization, and related pharmaceutical packaging equipment.
• Monitor process performance using manufacturing data, identify trends, and drive continuous improvement initiatives utilizing Lean Manufacturing and Six Sigma principles.
• Participate in cross-functional project meetings and provide engineering support during technology transfer, scale-up, and commercialization activities.

Requirements

• Bachelor's degree in Mechanical Engineering, Chemical Engineering, Pharmaceutical Engineering, Industrial Engineering, or a related engineering discipline.
• 3 years of experience in Oral Solid Dosage (OSD) pharmaceutical manufacturing or pharmaceutical process engineering.
• Hands-on experience with granulation, blending/mixing, roller compaction, tablet manufacturing, and packaging processes.
• Experience working with Architecture & Engineering (A&E) firms on pharmaceutical CAPEX projects.
• Preferred experience deploying and optimizing Glatt high-shear mixers (VG-600 or similar).
• Preferred experience with Gerteis Macro-Pactor or similar roller compaction equipment.
• Experience supporting potent compound processing, including containment systems, dust control, equipment cleaning, and EHS requirements.
• Knowledge of pharmaceutical packaging equipment and downstream packaging systems is highly desirable.
• Strong understanding of cGMP, FDA regulations, process validation, equipment qualification (IQ/OQ/PQ), and change management.
• Experience performing process troubleshooting, root cause analysis, risk assessments, and continuous improvement initiatives.
• Strong communication and collaboration skills with cross-functional teams including Manufacturing, Validation, Quality, Maintenance, and external engineering partners.
• Knowledge of Lean Manufacturing, Six Sigma, and project management methodologies is preferred.
• Ability to manage multiple projects simultaneously in a fast-paced pharmaceutical manufacturing environment while maintaining a strong focus on safety, quality, and compliance.
• F-1 OPT, CPT, and STEM OPT candidates are encouraged to apply. Visa sponsorship is available for qualified candidates, excluding H-1B sponsorship.

Pay: $75,000.00 - $80,000.00 per year

Work Location: In person

Salary : $75,000 - $80,000