Manufacturing Technician IV, Lead - Sterile Filling

Resilience • West Chester, OH

2d • Onsite

About The Position

The Manufacturing Technician IV, Lead supports sterile filling operations and leads complex filling batch activities on the manufacturing floor. The role serves as a technical resource for the team, performs advanced-level documentation review, and resolves technical production issues. The position also supports production and mechanical technicians, provides on-the-job training, and helps maintain safe, compliant, and efficient operations.

The role involves work in controlled/non-classified and classified cleanroom production areas requiring aseptic gowning. It is primarily non-sedentary and may include climbing, kneeling, standing, repetitive motion, temperature changes, moving objects with up to 100 pounds of force, and potential exposure to area chemicals requiring precautions. Employees must participate in an occupational health program, use required personal protective equipment, pass an eye exam during onboarding, and demonstrate and maintain gown qualification standards. Employees are expected to follow the company Quality Management System and applicable cGMP requirements and regulations.

The schedule is 12-hour day shifts on a 2-2-3 schedule. The company may modify schedules or request overtime based on business needs. Work authorization or visa sponsorship is not available. The position’s target base pay range is $26.00–$40.50 per hour; actual pay depends on factors including location, experience, qualifications, skills, and knowledge.

Requirements

• Significant experience in pharmaceutical, biotechnology, or cGMP-regulated manufacturing.
• Advanced knowledge of cGMP requirements, regulatory expectations, and quality systems, including deviations, CAPAs, audits, and inspections.
• Ability to independently and resourcefully resolve complex production issues and guide team members.
• Ability to read, write, speak, and understand English well enough to communicate complex technical information cross-functionally.
• Exceptional attention to detail and demonstrated ability to review critical documentation and records for accuracy.
• Strong mathematical, analytical, and problem-solving skills, including interpreting data, identifying trends, and developing solutions.
• Experience supporting investigations and root cause analysis and implementing corrective and preventive actions.
• Experience providing on-the-job training to peers while fostering compliance and continuous improvement.
• Ability to manage priorities, make informed decisions under pressure, and meet production goals while maintaining regulatory compliance.
• Ability to work effectively as part of a team in a fast-paced production environment.
• Ability to demonstrate and maintain gown qualification standards.
• Ability to pass an eye exam during onboarding.

Nice To Haves

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

Responsibilities

• Lead and monitor process execution activities to support successful production-floor operations.
• Serve as a technical resource and resolve complex production issues involving batch setup and execution, technical interventions, documentation, equipment operations, and safety and quality.
• Support production technicians and mechanical technicians.
• Make independent operational decisions and provide guidance to team members.
• Perform filter integrity testing as needed according to SOPs.
• Perform technician tasks including startup, equipment operation, batch execution, material handling, and cleaning.
• Assemble, disassemble, and sanitize filling equipment.
• Assist technical staff with preventive maintenance procedures as required.
• Manage inventory control and reconciliation activities using SAP.
• Complete advanced-level batch record and GMP documentation entries, including complex or non-routine documentation, and guide team members on documentation accuracy.
• Train and support team members as a certified on-the-job trainer for assigned equipment and process tasks.
• Support lean activities, including 5S, problem-solving, and continuous-improvement projects.
• Attend and actively participate in daily tier meetings.
• Support investigations and root cause analysis, and help implement corrective and preventive actions.
• Support audits and regulatory inspections, including interactions with internal and external auditors.

Benefits

• Annual cash bonus program.
• 401(k) plan with a company match.
• Medical, dental, and vision healthcare coverage.
• Family-building benefits.
• Life and disability insurance.
• Paid vacation.
• Paid holidays.
• Other paid leaves of absence.
• Tuition reimbursement.
• Support for caregiving needs.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed