GMP Manufacturing Lead — Lean Process & Training

Civica; Petersburg (VA); On-site; USD 65,000 - 110,000; Full time

Job summary

The Manufacturing Support Lead at Civica drives daily operations, mentoring associates and delivering frontline technical leadership to ensure safe, compliant pharmaceutical manufacturing. You will coordinate across shifts, support equipment qualification, drive process improvements, and maintain rigorous documentation and SOP governance.

On-site in Virginia, this role emphasizes Lean principles, cGMP compliance, and collaboration with cross-functional teams to sustain production efficiency and

Qualifications

• 3+ years of operations or manufacturing support experience in pharma (cGMP, FDA, ISO).
• Experience with autoclaves, parts washers, and manufacturing support equipment.
• Team lead, trainer, or informal leadership in GMP manufacturing preferred.
• Knowledge of process improvement, change management, and investigations.
• Lean Manufacturing and/or Six Sigma experience preferred.

Responsibilities

• Provide daily direction, coordination, and support to Manufacturing Associates during routine operations.
• Act as a subject matter expert for manufacturing support processes including autoclaves, parts washers, CIP, and MTIs.
• Support equipment qualification, commissioning, validation, and start-up activities.
• Serve as the primary point of contact for operational issues and elevate concerns to supervision when necessary.
• Assist with maintaining inspection readiness and support regulatory inspections and audits.
• Ensure personnel are trained and qualified prior to performing assigned activities.
• Support development, revision, and implementation of SOPs, batch records, and governing documents.
• Promote compliance with FDA, cGMP, ISO, safety, and company requirements.
• Identify and implement process improvements using Lean Manufacturing principles.
• Assist with investigations, root cause analysis, deviations, CAPAs, and change controls.
• Mentor and train associates on technical processes, documentation practices, and operational excellence.
• Coordinate activities across shifts and departments to ensure operational continuity and effective communication.
• Maintain accurate production and compliance documentation.
• Provide operational feedback to leadership regarding staffing, training, and process improvement opportunities.
• Maintain flexibility to support production schedules and business needs.
• Ability to work on-site is required.

Education

High school diploma or equivalent

Tools

Autoclaves

Parts washers

Clean-in-place (CIP)

Material transfer isolators (MTIs)

Job description

The Manufacturing Support Lead at Civica drives daily operations, mentoring associates and delivering frontline technical leadership to ensure safe, compliant pharmaceutical manufacturing. You will coordinate across shifts, support equipment qualification, drive process improvements, and maintain rigorous documentation and SOP governance.

On-site in Virginia, this role emphasizes Lean principles, cGMP compliance, and collaboration with cross-functional teams to sustain production efficiency and