Manufacturing Technician IV, Lead - Inspection (PFS 2 Days

The Manufacturing Technician IV, Lead

The Manufacturing Technician IV, Lead reports to a Supervisor/Manager on the Manufacturing floor and leads Inspection floor activities. The Lead serves as the first-line team resource, manages batch record review, oversees team qualification status, and drives continuous improvement in partnership with Process Facilitators and Engineers.

• Lead and monitor process execution activities to ensure successful operations on the production floor.
• Perform inspection activities as needed to support floor coverage and qualification maintenance.
• Perform inventory control and reconciliation activities using SAP and WES.
• Execute protocols as required as part of equipment qualification and process validation work.
• Ensure work requirements are followed on the production floor in accordance with SOPs and cGMPs.

• Manage batch records and GMP documentation on the production floor; review documentation completed by Tech II and III team members.
• Access and print SOPs and forms via ECMS as required; ensure team adherence to current revisions.
• Follow and reinforce job-related safety procedures including PPE use, LOTO, ergonomics, and chemical handling.
• Use process documents including SOPs, forms, and batch records to guide work and ensure requirements are followed on the production floor, in accordance with SOPs and cGMPs.
• Support lean activities including 5S, problem-solving, and serving as CI project resource for the PET.

• Maintain all required certifications and qualifications for the assigned work area.
• Act as first-line resource for the team; provide support to production and mechanical technicians.
• Act as certified OJT trainer on assigned equipment and process tasks; train and evaluate team members.
• Oversee and maintain team qualification and certification status.
• Work alongside Process Facilitators and Engineers to create a collaborative environment for all operators.
• Apply first-line management skills including situational leadership and daily operational decision-making.
• Support deviation investigations, CAPA execution, and SOP revisions as the inspection floor SME.
• Attend and actively participate in daily Tier 1 meetings.

• Demonstrated expertise across all inspection types and equipment, with prior experience leading floor execution in a pharmaceutical or regulated manufacturing environment.
• Significant experience in a pharmaceutical or regulated manufacturing environment.
• Advanced knowledge of cGMP requirements, inspection processes, documentation practices, and investigation support.
• Mastery of visual defect detection and inspection accuracy across all material types handled on the floor.
• Demonstrated leadership experience including coordinating team activities, providing direction, and supporting daily production operations.
• Proven ability to review, approve, and ensure accuracy of critical GMP documentation and batch records.
• Strong organizational, analytical, and problem-solving skills with the ability to coordinate personnel and prioritize operations.
• Experience training, coaching, and developing team members while fostering a culture of compliance and continuous improvement.
• Ability to effectively read, write, speak, and understand English to communicate technical information and lead cross‑functional discussions.
• Ability to work effectively as part of a team in a fast‑paced production environment.
• Ability to work overtime as needed.
• Ability to pass eye exam during onboarding.

• High school graduate, vocational school graduate, or equivalent.
• 4+ years of experience in a pharmaceutical or regulated manufacturing environment.
• Prior inspection experience.
• Prior supervisory or team leadership experience.
• Experience in metrics tracking and reporting.
• Experience leading inspection process improvements, deviation investigations, and qualification programs.
• Working knowledge of Microsoft applications, SAP and/or Veeva Vault.

This role is primarily a non‑Sedentary role. This can include climbing, kneeling, repetitive motion, temperature changes, and…