Manufacturing Lead, Vial Fill & Process Improvement

Civica; Petersburg (VA); On-site; USD 120,000 - 160,000; Full time

Job summary

Civica is seeking a Manager, Manufacturing, Vial Fill for our Petersburg, VA site to lead daily operations and ensure timely production of injectable products. You will participate in qualifications, develop SOPs, and drive process improvements with a strong Lean mindset.

The role requires 8+ years in regulated production, expertise in high-speed fill/finish, and proven leadership in driving CAPA, investigations, and cross-functional collaboration.

Qualifications

• Bachelor's degree with 8+ years of demonstrated ability in a cGMP FDA, cGMP, ISO, or other regulated production environments.
• Advanced experience in a process improvement environment, including project management, change management, and leading Lean/Six Sigma project teams.
• Prior high-speed fill/finish (vial, cartridge, PFS, etc.) experience required.
• Expert facilitation skills with demonstrated results.
• Interact with other functions and take ownership of assigned projects.

Responsibilities

• Under the Director of Manufacturing’s direction, actively participate in new equipment and process qualifications.
• Develop and create standard operating procedures, specifications, and other forms of governing documents to delineate manufacturing process requirements according to qualification, compliance, and business requirements.
• Ensure that the Manufacturing organization operates to meet the requirements of approved production plans at minimum costs within established quality limits and in accordance with FDA, cGMP, ISO, and OSHA requirements.
• Responsible for identifying opportunities to improve customer service, quality, safety, performance, scrap minimization, or otherwise reduce manufacturing costs by using effective project management, cost control techniques, and Lean Manufacturing.
• Mentors, coaches, and teaches Manufacturing Associates in the use of statistical tools, Lean/Six Sigma methodologies, and change management/control techniques to ensure timely completion of projects with the expected results.
• Utilizes scientific methods and statistical tools to perform investigations, root cause analyses, and impact assessments in support of timely resolution of deviations/discrepancies related to Manufacturing.
• Identifies corrective and preventive actions (CAPA) and leads projects to completion within project timelines. Verify effectiveness of CAPA by post-project data collection and analysis.
• Demonstrated ability to act as subject matter expert in manufacturing equipment build and function, as well as in manufacturing processes, including aseptic filling, isolator/RABs technology, and packaging.
• Flex schedule to meet commitments and achieve milestones related to projects, production, and other demands of the role.

Skills

Lean Six Sigma

Project management

Regulatory compliance

Communication

Problem solving

Education

Bachelor's degree + 8+ years regulated production experience

Job description

Civica is seeking a Manager, Manufacturing, Vial Fill for our Petersburg, VA site to lead daily operations and ensure timely production of injectable products. You will participate in qualifications, develop SOPs, and drive process improvements with a strong Lean mindset.

The role requires 8+ years in regulated production, expertise in high-speed fill/finish, and proven leadership in driving CAPA, investigations, and cross-functional collaboration.