Manufacturing Operations Lead - GMP & Process Improvement

RXinsider LTD.; Petersburg (VA); On-site; USD 90,000 - 120,000; Full time

Job summary

Civica in Petersburg, VA seeks a Manufacturing Support Supervisor to lead daily operations for injectable production, supporting equipment qualifications and process improvements. You will mentor a team, ensure training and qualification, and drive CAPA and change management to meet FDA, cGMP, and ISO standards.

The role requires strong leadership, documentation, and problem-solving skills, with a focus on safety, quality, and continuous improvement in a fast-paced manufacturing environment.

Qualifications

• Bachelor's degree required with 4+ years in a cGMP FDA/ISO environment or an associate's degree with 6 years in cGMP production
• Experience with Autoclaves and Parts Washers
• 1+ year supervisory experience in GMP manufacturing
• Process improvement, change management, and leading teams
• Lean Manufacturing/Six Sigma Green Belt preferred
• Strong writing and documentation skills
• Self-directed with analytical and problem-solving skills
• Strong interpersonal and leadership skills

Responsibilities

• Participate in new equipment and process qualifications under senior guidance
• Serve as SME in manufacturing processes including autoclaves, CIP, MTIs
• Escalate and own business, technical, and compliance decisions
• Maintain inspection readiness and support tours as SME
• Ensure staff are trained and qualified for activities
• Ensure safe, compliant production meeting quality and supply needs
• Develop SOPs and governing documents for manufacturing requirements
• Aim to meet production plans at minimum cost while complying with FDA, cGMP, ISO, OSHA
• Identify opportunities to improve service, quality, safety, or reduce costs using Lean tools
• Coach staff on change management techniques and project execution
• Use investigative methods and CAPA processes to resolve deviations
• Identify CAPA and drive projects to completion with evidence of effectiveness
• Maintain on-site presence and adjust schedule to meet milestones
• Approve staff timecards

Skills

Leadership

Documentation

Problem-solving

Communication

Analytical skills

Change management

Lean Manufacturing

Education

Bachelor's degree in a relevant field

Associate’s degree + 6 years cGMP experience

Tools

Autoclaves

Parts washers

CIP / MTIs

Job description

Civica in Petersburg, VA seeks a Manufacturing Support Supervisor to lead daily operations for injectable production, supporting equipment qualifications and process improvements. You will mentor a team, ensure training and qualification, and drive CAPA and change management to meet FDA, cGMP, and ISO standards.

The role requires strong leadership, documentation, and problem-solving skills, with a focus on safety, quality, and continuous improvement in a fast-paced manufacturing environment.