API Process Project Engineer
Remote – with travel
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.
Process Engineer
Purpose
The Process Engineer will provide technical support for manufacturing processes within a pharmaceutical production environment. This role is responsible for optimizing process performance, supporting troubleshooting and problem resolution, driving process improvements, and ensuring reliable, compliant, and efficient operations. The Process Engineer will work closely with Operations, Quality, Engineering, Validation, and other cross-functional partners to support safe and consistent manufacturing outcomes.
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.
Qualifications
- Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Bioprocess Engineering, or a related technical discipline required.
- Proven experience as a Engineer within a pharmaceutical manufacturing environment, API
- Knowledge of process engineering principles, manufacturing operations, and problem-solving methodologies.
- Experience with technical investigations, process improvements, and change control processes preferred.
- Strong analytical, organizational, and communication skills.
- Ability to work effectively in a cross-functional, fast-paced environment.
Job Type: Full-time
Work Location: Remote
