Factory Service Engineer

Responsibilities

• Perform installations, routine maintenance, and troubleshooting of Cellares and other process equipment within a Good Manufacturing Practice (GMP) environment in a cell therapy manufacturing facility
• Collaborate with cross-functional teams to ensure compliance with GMP standards and regulations
• Perform equipment End of Line testing, calibrations, and support validation testing to meet quality and regulatory requirements
• Respond promptly to equipment failures and implement corrective actions to minimize downtime. Execute preventive maintenance activities to ensure optimal functionality of manufacturing equipment
• Maintain accurate documentation of all maintenance activities and equipment logs in a Computerized system
• Maintenance Management System (CMMS)
• Manage parts ordering and coordinate with equipment and area owners to schedule maintenance activities
• Maintain tools and test equipment, and ensure they are properly calibrated and in good, safe working condition
• Collaborate with manufacturing and quality control teams to address technical issues and optimize processes
• Support Quality Change Controls and CAPA investigations
• Stay updated on industry trends and advancements to contribute to continuous improvement initiatives
• Participate in training programs to enhance technical skills and knowledge
• Participating in an after-hours on-call rotation to support GMP facility operations is required and managed through PagerDuty
• Experience drafting and maintaining Standard Operating Procedures (SOPs) and Work Instructions (WIs)

Requirements

• Bachelor’s degree or equivalent in engineering or a related field 
• 3+ years’ experience in a GMP manufacturing environment, preferably in cell therapy or biopharmaceuticals
• Basic understanding of GMP regulations and quality standards
• Experience as a technical/service lead on a multi-subsystem installation/qualification
• Proficient in troubleshooting and repairing complex manufacturing equipment
• Ability to read and understand technical documents and engineering drawings
• Excellent organizational and documentation skills
• Ability to work collaboratively in a team-oriented environment
• Effective communication skills to interact with diverse stakeholders
• Must be able to work a full-time, 40-hour workweek, including weekends and holidays, as required to support business needs (Training will be performed during the day shift)
• Attendance at the plant site is considered an essential function
• Detail-oriented with a commitment to maintaining high-quality standards
• Must be able to lift and carry up to 50 lbs
• Excellent verbal, written, organizational, presentation, and interpersonal skills
• Self-awareness, integrity, authenticity, and a growth mindset
 
Preferred Experience
 
• Experience with PLC automated control systems
• Experience with 6-axis robots
• Experience working safely with high voltage systems (208V)
• Experience with Blue Mountain CMM