Senior Process Engineer

Responsibilities

• Monitor and analyze manufacturing data to support process optimization and investigations.
• Participate in process FMEAs to evaluate process and product risks prior to validation activities.
• Provide mentorship and training to team members.
• Ensure readiness and success of process comparability studies and validation runs by assessing risks, implementing preventive measures, and troubleshooting equipment or process issues.
• Lead DMAIC-based investigations to identify root causes, assess impact, and recommend improvements to maintain and enhance manufacturing operations.
• Collaborate with cross-functional teams to support ongoing production activities.
• Contribute to the assessment and potential implementation of new technologies and process automation within GMP manufacturing environments.
• Prepare technical documentation, including protocols and reports for equipment and instrument qualification, comparability work, process studies, and process validation.
• Execute engineering studies, develop recipes, and perform validation test cases.
• Work with external vendors and suppliers to define requirements and understand equipment or system specifications.
• Adapt to evolving operational needs within the manufacturing environment.
• Work flexible hours as needed to support production schedules.

Qualifications

• Experience with sterile injectable operations (e.g., formulation, aseptic filling, inspection, packaging).
• Knowledge of data management tools and root cause analysis methodologies.
• Bachelor’s degree or higher in engineering, bioengineering, or a related scientific discipline.
• Minimum of 5 years of experience in biopharmaceutical manufacturing or another GxP-regulated industry.
• Experience working with contract manufacturing or contract development organizations.
• Technical certifications and/or Lean Six Sigma credentials.
• Hands-on electro-mechanical experience.