Process Engineer – Pharmaceutical
HybridWhippany, New Jersey, United States
Job Summary
Lead technical investigations for process deviations, out-of-trend results, and equipment performance issues across Oral Solid Dosage and sterile manufacturing operations. Apply root cause analysis to develop effective CAPAs and perform process risk assessments including FMEA and HACCP. Develop and maintain continuous process verification programs while monitoring critical process parameters and attributes to ensure product quality. Plan and execute equipment qualification activities and support technology transfers for new equipment and process modifications. Collaborate with cross-functional teams to implement operational excellence initiatives using Lean, Six Sigma, and Kaizen methodologies. Manage equipment lifecycle activities from design through decommissioning and provide technical expertise for serialization and aggregation processes.
Required Qualifications
- Bachelor's or master's degree in Chemical Engineering, Mechanical Engineering, Pharmaceutical Engineering, or related field
- 5-10 years' experience in pharmaceutical manufacturing, covering both OSD and sterile operations
- Proven track record in process validation, CPV, and equipment qualification
- Experience in root cause investigation, CAPA management, and regulatory audits (FDA, EMA, MHRA)
- Exposure to serialization and aggregation systems and related compliance standards
- Working knowledge of reliability engineering and Operational Excellence tools
- Strong analytical and problem-solving capabilities with proficiency in tools such as Minitab, MS Project, MS Tools, etc.
- Solid understanding of cGMP, ICH Q8-Q10, Annex1, 21CFR 210/211/820, ISO 13485 and data integrity principles
- Excellent communication, presentation, and technical writing skills
- Ability to work cross-functionally and manage multiple projects simultaneously
- Self-motivated, detail-oriented, and committed to continuous improvement
Desired Qualifications
- Lean Six Sigma Green Belt / Black Belt
- Certified Reliability Engineer (CRE)
- PMP (Project Management Professional)
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