Job DescriptionDescription:The Process Engineer supports the compliant, efficient, and safe operation and technology transfer of sterile manufacturing processes from development through commercial scale. The role executes process and cleaning validation activities, analyzes manufacturing data, assists with scale-up and aseptic process simulations, and contributes to troubleshooting and continuous improvement. Working with Manufacturing, Quality, Validation, Engineering, R&D, and vendors, the engineer supports formulation, filling, packaging, lyophilization, dehydrogenation, sterilization, and contamination-control processes under appropriate technical guidance.
Essential Functions:- Authors and executes protocols and reports in accordance with FDA, cGMP, and site requirements for process validation, cleaning validation, and assigned equipment or automation qualification activities. Monitors and analyzes manufacturing data to support continued process verification, process lifecycle management, investigations, deviations, and resolution of process anomalies.
- Supports technical plans, process assessments, project scopes, risk assessments, and schedules for establishing manufacturing capability and introducing new or reformulated products. Coordinates with R&D, Manufacturing, Quality, and Validation to support technology transfer, scale-up, aseptic process simulations, and process performance qualification. Assists with feasibility evaluations and implementation of technologies that improve manufacturing capability.
- Provides day-to-day technical support and troubleshooting for manufacturing processes and equipment. Supports start-up of new processes or equipment, prepares manufacturing instructions, and trains operations personnel. Evaluates quality, yield, throughput, cycle time, process parameters, cGMP compliance, safety, and environmental requirements. Collaborates with vendors and technical specialists to review requirements and functional specifications for filling, sterilization, decontamination, and environmental-control systems.
- Supports chemical and biological formulation, filling, packaging, lyophilization, depyrogenation, and contamination-control operations. Drafts and revises SOPs, process instructions, and batch records. Initiates or supports change controls and impact assessments; participates in investigations, root-cause analysis, data review, and CAPA implementation; and maintains accurate process knowledge and lifecycle documentation.
Additional Responsibilities:- Reviews and updates P&IDs, process flow diagrams, equipment layouts, engineering drawings, and process engineering documents.Occasional international and national travel is required for new projects. Applies project management principles to track assigned timelines, actions, and risks and to communicate effectively with cross-functional teams.
QualificationsEducation:- Bachelors Degree (BA/BS) Chemical, Mechanical, Biomedical, Manufacturing Engineering, or a related technical or scientific field - Required
- Master Degree (MS/MA) Engineering or a related technical or scientific field - Preferred
Experience:- 2 years or more in Experience in process engineering or manufacturing support in a GMP-regulated pharmaceutical, biotechnology, or life-sciences environment.
- 2 years or more in Experience with sterile or aseptic manufacturing
Specialized Knowledge:- Working knowledge of cGMP, FDA regulations, data integrity principles, and applicable quality-system requirements. Ability to author and execute protocols, analyze data, document results, and prepare clear technical reports. Practical problem-solving, troubleshooting, risk-assessment, and root-cause analysis skills with appropriate guidance. Strong communication and interpersonal skills and the ability to coordinate assigned tasks across cross-functional teams. Proficiency with Microsoft Office and familiarity with statistical analysis, process historian, MES, or engineering drawing tools.
The base salary for this position ranges from $80,000 to $95,000 per year. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, with this position within the first 12 months. Amneal ranges reflect the Company's good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills.
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