Harba Solutions Inc.
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.
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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.
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