Process Engineer Job Description
The Process Engineer plays a pivotal role in ensuring the smooth operation of our manufacturing processes.
* Ensure compliance with global policies, procedures, and guidelines, as well as adherence to current Good Manufacturing Practices (cGMP).
* Design, author, review, approve, and execute qualification documentation in line with standard process protocols.
* Lead experimental design of studies, execution, data analysis, and interpretation to inform process improvements.
* Support the execution of development and production batches, change control management, and implementation.
* Lead multidisciplinary teams for process improvement and troubleshooting through Lean Six Sigma methodologies.
Maintain continuous focus on quality and safety compliance and customer satisfaction. Key qualifications include expertise in upstream/downstream processing and process control strategies, working knowledge of analytics, and regulatory requirements for biologics processes.
Key Responsibilities:
* Spearhead process excellence initiatives, driving efficiency and effectiveness across the organization.
* Develop and maintain thorough understanding of manufacturing processes, identifying areas for improvement and implementing corrective actions.
* Collaborate with cross-functional teams to resolve complex technical issues and optimize process outcomes.
We are seeking an experienced Process Engineer who can bring valuable insights and skills to our team, helping us drive innovation and excellence in our manufacturing operations.