Aseptic Equipment Specialist

Responsibilities:

• Execute and document routine activities including equipment setup, start-up, teardown, and cleaning procedures in aseptic manufacturing suites
• Own and optimize fill line equipment performance through preventive maintenance, repair coordination, and equipment reliability analysis
• Collaborate with operations, quality, and engineering teams to support validation, investigations, and continuous improvement initiatives
• Perform in-process checks and support batch documentation in compliance with current Good Manufacturing Practices (cGMP)
• Lead or assist with line changeovers, component configuration, and troubleshooting during aseptic fills
• Support deviation resolution and root cause analysis with cross-functional partners
• Champion safety, product quality, and operational efficiency in all aspects of equipment performance

Qualifications:

• Experience with isolator-based aseptic fill/finish operations or barrier technology
• Familiarity with cleanroom gowning requirements and GMP documentation
• Proficiency in mechanical troubleshooting and basic automation interfaces (e.g., HMI screens)
• Ability to work collaboratively and communicate effectively within a cross-functional manufacturing environment