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The Process Engineer is responsible for developing, optimizing, validating, and sustaining fabrication processes and equipment for microneedle fabrication within a pharmaceutical environment. This role plays a critical part in scaling processes from development to full commercial production, ensuring that all fabrication operations meet quality, safety, and efficiency standards in compliance with FDA 21 CFR Part 210, 211, 820, ISO 13485 and applicable GMP regulations.
The ideal candidate possesses a strong foundation in processing, formulation, or drug delivery fabrication, combined with a systematic approach to process development, troubleshooting, and continuous improvement. The Process Engineer collaborates closely with Quality, R&D, and Operations/Admin teams to deliver reliable, validated fabrication processes and methods.
KEY RESPONSIBILITIES
Process Development & Optimization
- Design, develop, and optimize fabrication processes for microneedle arrays, including molding and assembly operations.
- Conduct process characterization studies to identify critical process parameters (CPPs) and their impact on critical quality attributes (CQAs).
- Apply Design of Experiments (DOE) methodologies to systematically evaluate process variables and establish robust operating ranges.
- Develop and maintain process control strategies, including in-process controls, statistical process control (SPC) charts, and control plans.
- Generate and maintain process flow diagrams, PFMEAs, and technical risk assessments for fabrication operations.
Process Validation & Qualification
- Lead and execute process validation activities (IQ/OQ/PQ) for microneedle fabrication equipment and processes in accordance with FDA Process Validation Guidance (2011) and ASTM E2500.
- Author and execute validation protocols, reports, and summary documents; ensure timely review and approval through the document control system.
- Support equipment qualification (DQ/IQ/OQ) for new or modified fabrication equipment, including cleanroom tools, dispensing systems, and inspection equipment.
- Collaborate with Quality Assurance to ensure all validation activities meet regulatory requirements and are properly documented in the batch record system.
Fabrication Support & Troubleshooting
- Provide day-to-day technical support to production operations for microneedle fabrication, including resolving process deviations, yield losses, and equipment issues.
- Investigate and resolve fabrication nonconformances, out-of-specification (OOS) results, and product defects using structured problem-solving methodologies (RCCA, 8D, Fishbone, 5 Whys).
- Initiate and support CAPAs related to fabrication process failures; verify effectiveness of implemented corrective actions.
- Assist in the review and disposition of batch records and fabrication documentation to support product release.
New Product Introduction (NPI) & Technology Transfer
- Support the transfer of new microneedle products and processes from R&D to fabrication, including development of SOPs, work instructions, and training materials.
- Participate in design for manufacturability (DFM) reviews and provide fabrication input during product development stages.
- Collaborate with R&D and Quality on the fabrication sections of product submissions (when and where applicable for 510(k), NDA, ANDA, or equivalent).
- Define and validate packaging processes and maintain compatibility assessments for microneedle drug-device combination products.
Continuous Improvement & Lean Fabrication
- Identify and implement continuous improvement opportunities to increase production efficiency, reduce scrap/rework, and improve overall equipment effectiveness (OEE).
- Apply Lean and Six Sigma tools (5S, kaizen, value stream mapping, DMAIC) to drive measurable process improvements.
- Track and analyze fabrication KPIs including cycle time, yield, throughput, and first pass quality to identify improvement opportunities.
- Evaluate and introduce new materials, equipment, or techniques to enhance microneedle fabrication capabilities.
Documentation & Regulatory Compliance
- Author, revise, and approve fabrication SOPs, work instructions, batch record templates, and engineering specifications in compliance with controlled document procedures.
- Ensure all engineering changes are processed through the Change Control system with appropriate risk assessments and validation support.
- Support internal quality audits, regulatory inspections (FDA, ISO), and customer audits by providing process documentation and technical expertise.
- Maintain compliance with cleanroom protocols, environmental monitoring requirements, and PPE standards for classified fabrication areas.
QUALIFICATIONS
Required Education & Experience
- Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, Pharmaceutical Sciences, Life Sciences, or a related technical field.
- Minimum 3-5+ years of process engineering experience in a regulated medical device, pharmaceutical, or combination product fabrication environment.
- Demonstrated experience with process validation (IQ/OQ/PQ), process development, and technical troubleshooting in a GMP fabrication setting.
- Working knowledge of FDA 21 CFR Part 210, 211, 820 (QSR), ISO 13485, and FDA Process Validation Guidance.
- Familiarity with cleanroom fabrication protocols and gowning requirements (ISO Class 7/8).
Preferred Qualifications
- Experience with microneedle, transdermal drug delivery, or related microfabrication processes (e.g., micro molding, coating, dissolving polymer formulation).
- Six Sigma Green Belt or Black Belt certification; experience with DOE and SPC tools (e.g., Minitab, JMP).
- Familiarity with FES/MES (Fabrication Execution Systems/Manufacturing Execution Systems) and ERP platforms used in regulated fabrication environments.
- Experience with mechanical or optical inspection systems for small-scale medical devices.
- Knowledge of biocompatibility standards (ISO 10993) and sterility assurance for medical device fabrication.s
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