API Process Project Engineer
Chicago - Onsite
Company Overview
Gertek is a leading technical services provider dedicated to delivering high-quality engineering, compliance, and project management solutions to the life sciences and pharmaceutical industries. We pride ourselves on our technical expertise and our ability to partner with global clients to bring life-saving products to market safely and efficiently. As we continue to expand our operations, we are seeking a dedicated API Process Project Engineer to join our professional team.
Role Overview
The API Process Project Engineer will provide remote project support for Active Pharmaceutical Ingredient (API) manufacturing projects. This role bridges process engineering and project execution, ensuring that both new and existing products, equipment modifications, and process changes are supported with a focus on technical excellence, safety, and regulatory compliance, matching the structural standards found in the API Project Engineer.docx file.
Key Responsibilities
- Support day-to-day manufacturing operations by providing technical expertise for assigned processes and equipment.
- Investigate process issues, identify root causes, and implement corrective and preventive actions to improve performance and reliability.
- Partner with Operations, Quality, Engineering, Validation, and Maintenance to support process troubleshooting and continuous improvement initiatives.
- Analyze process data, trends, and performance metrics to identify opportunities for optimization, efficiency improvement, and waste reduction.
- Support process characterization, scale-up, qualification, and validation activities as needed.
- Review and update process documentation, including batch records, work instructions, technical reports, and change control documentation.
- Assist in the implementation of process changes, equipment modifications, and new technologies in accordance with site procedures and quality requirements.
- Participate in risk assessments, technical investigations, and project meetings as a subject matter resource for assigned processes.
- Support compliance with cGMP, safety, and regulatory requirements in all process-related activities.
- Collaborate with cross-functional teams to ensure robust process execution and sustainable improvement.
Requirements
- Proven experience as a Project or Process Engineer within an API or pharmaceutical manufacturing environment.
- Strong technical proficiency in reviewing, updating, and developing process documentation (such as PFDs, P&IDs, and batch records).
- In-depth understanding of cGMP environments, validation activities, and global FDA regulatory requirements.
- Experience participating in risk assessments, technical investigations, PHA, and Hazops.
- Ability to collaborate effectively with cross-functional, remote teams to troubleshoot processes and support equipment modifications.
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