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
