Maintenance Technician IV, Lead - Sterile Operations (Night Shift)

The Manufacturing Technician IV, Lead supports Filling operations. The position leads complex filling batch activities on the manufacturing floor, serves as a technical resource for the team, performs advanced-level documentation review, and resolves technical production issues. 

Job Responsibilities 

Operations 

• Lead and monitor process execution activities to ensure successful operations on the production floor. 
• Serve as a technical resource for the team; resolve complex production-related issues including batch setup, execution, technical interventions, documentation, equipment operations, and safety/quality. 
• Provide support to production technicians and mechanical technicians. 
• Apply strong organizational and problem-solving skills to make independent decisions and provide guidance to team members on daily operational activities. 
• Perform and execute filter integrity testing as needed per SOP. 
• Perform technician tasks as required, including start-up, equipment operation, batch execution, material handling, and cleaning. 
• Assemble, disassemble, and sanitize various Filling equipment. 
• Assist technical staff with preventive maintenance procedures, as required. 
• Manage inventory control and reconciliation activities using SAP. 

Documentation & Compliance 

• Perform advanced-level batch record and GMP documentation entries on the production floor, including complex or non-routine documentation; provide guidance to team members on documentation accuracy. 

Training & Development 

• Serve as a technical resource for the team, providing subject-matter support to production and mechanical technicians. 
• Act as a certified OJT trainer on assigned equipment and process tasks, training and supporting team members. 
• Support lean activities such as performing 5S and participating in problem-solving and CI projects. 
• Attend and actively participate in daily tier meetings. 

Minimum Qualifications 

• Significant experience in a pharmaceutical, biotechnology, or cGMP-regulated manufacturing environment. 
• Advanced knowledge of cGMP requirements, regulatory expectations, and quality systems, including deviations, CAPAs, audits, and inspections. 
• Demonstrated ability to work independently and resourcefully to resolve complex production issues and provide guidance to team members. 
• Ability to effectively read, write, speak, and understand English to communicate complex technical information cross-functionally. 
• Exceptional attention to detail with proven ability to review and ensure accuracy of critical documentation and records. 
• Strong mathematical, analytical, and problem-solving skills, with the ability to interpret data, identify trends, and drive solutions. 
• Proven ability to support investigations, root cause analysis, and implementation of corrective and preventive actions (CAPAs). 
• Experience providing on-the-job training to peers while fostering a culture of compliance and continuous improvement. 
• Ability to manage own priorities, make informed decisions under pressure, and ensure production goals are met while maintaining regulatory compliance. 
• Experience supporting audits and regulatory inspections, including interacting with internal and external auditors. 
• Ability to work effectively as part of a team in a fast-paced production environment. 

Preferred Qualifications 

• High school graduate, vocational school graduate, or equivalent. 
• 4+ years of experience in a pharmaceutical, biotechnology, or cGMP-regulated manufacturing environment. 
• Experience working in a lean manufacturing environment. 
• Working knowledge of Microsoft applications, SAP and/or Veeva Vault. 

Physical & Work Environment  

• Work is performed in Controlled/Non-Classified and Classified (cleanroom) production areas requiring aseptic gowning. This is primarily a non-Sedentary role that can include climbing, kneeling, standing, repetitive motion, temperature changes, exerting up to 100 pounds of force to move objects, and potential exposure to area chemicals requiring handling precautions per SOP. 
• Visual acuity such as working with data & figures, viewing computer terminals, extensive reading, operating machinery, operating motor vehicles, general observations of facilities, etc. 
• Participation in an occupational health program, which can include medical assessment, surveillance, vaccination, and testing. 
• Use of personal protective equipment, which can include respirators, Personal Air Purifying Respirators [PAPR], gowns, gloves, face protection, other barrier equipment, etc. 
• All employees are expected to adhere to the Quality Management System established in the Quality Manual, Quality Policy, Standard Operating Procedures, Current Good Manufacturing Practices, and any other applicable regulations and standards to the duties within their role. ​ 
• Ability to pass eye exam during onboarding. 

Work Schedule:  

Night Shift position working 6pm - 630am on a 12 hour rotation of 2 nights on, 2 nights off, 3 nights on, and 3 nights off with the rotation starting over again.

The work schedule listed reflects the employee’s expected schedule at the time of hire. The Company reserves the right to modify work schedules at any time, including a request to work overtime, with or without notice, based on business needs, operational requirements, or other considerations. Nothing in this description creates a guarantee of specific hours, days, or shift assignments.