Manufacturing Specialist II – 2nd Shift

Position Summary

We are looking for a Manufacturing Specialist II – 2^nd shift who will play a key part in the facility start up with primary responsibilities focused around supporting daily manufacturing operations on the nested line and the timely production of pharmaceuticals. 

Duties & Responsibilities

• Collaborate with Manufacturing, Quality Operations, Environmental Health and Safety and other cross-functional teams to meet production needs.
• Support onboarding and provide technical training of Manufacturing Operators on process equipment including Fillers with integrated Isolators, ATEC commodities processing, Parts Washer, Autoclaves, Single Use Technology, and Aseptic Process Simulations.
• Initiate and complete manufacturing investigations including root cause analysis and product impact assessment.
• Drive the creation, revision, and management of manufacturing documents such as Batch Records and SOPs.
• Lead efficient GMP document and record reviews to minimize routing time.
• Provide technical expertise and support regulatory inspections as an SME for the area.
• Ability to quickly adapt and adjust priorities in response to changes in the production schedule due to unforeseen disruptions with the intent to minimizing impact to operations.
• Onsite presence, as the role requires time on the manufacturing floor and cross-functional collaboration. 
• Develop and track KPI metrics to identify opportunities, failure points, and trending models.
• Flex schedule to work outside routine 2nd shift hours at times to accommodate activities as needed.  

Required Qualifications    

• Associate degree with 6+ years demonstrated ability in a cGMP production environment. High School degree with 8+ years of experience of cGMP production experience may be considered.
• Experience with sterile fill finish manufacturing.
• Detailed-oriented with a focus on accuracy in creating and updating production documents.
• Knowledge of GMP, regulatory requirements, and industry best practices.
• Proficiency in Microsoft Office suite. Strong communication and collaboration skills, with a commitment to meeting high-quality standards. 
• Must be able to complete eye exam and have the visual ability to detect defects. 
• Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment.
• Basic math skills to perform required calculations (multiplication/division), 
• Good deviation and investigation writing skills. 
• Ability to work autonomously and within established guidelines, procedures, and practices.  

Preferred Qualifications

• Knowledge of high-speed aseptic filling and barrier system technology (isolator, RABS).
• Experience with single-use components in drug product formulation, sterile filtration, and aseptic filling applications.
• Equipment qualification experience.
• Experience in using ERP systems.