Vial Fill Manufacturing Leader

Civica, Inc.; Petersburg (VA); Sur place; USD 130 000 - 190 000; Plein temps

Résumé du poste

Civica, Inc. in Petersburg, VA is seeking a Manager of Manufacturing, Vial Fill, to help startup and support daily operations, ensuring timely production of pharmaceuticals and quality injectables.

You will lead a manufacturing team, participate in equipment qualifications, drive Lean/Six Sigma initiatives, perform investigations and CAPAs, and assure compliance with FDA, cGMP, ISO and OSHA, with a flexible schedule to meet project milestones.

Qualifications

• Bachelor's degree required with 8+ years in cGMP/regulated production environments.
• Advanced experience in process improvement, project management, and leading Lean/Six Sigma teams.
• Prior high-speed fill/finish (vial, cartridge, PFS) experience required.
• Strong communication and ownership of assigned projects.

Responsabilités

• Participate in new equipment and process qualifications under the Director of Manufacturing.
• Develop and maintain SOPs, specifications, and governing documents.
• Ensure production plans are met at minimum cost while complying with FDA, cGMP, ISO, OSHA.
• Identify opportunities to improve service, quality, safety, performance, and cost using Lean techniques.
• Mentor Manufacturing Associates in statistics, Lean/Six Sigma, and change management.
• Perform investigations and CAPA analyses to resolve deviations and verify effectiveness.
• Act as SME in equipment build, aseptic filling, isolator/RABs tech, and packaging.
• Maintain flexible scheduling to meet project milestones and commitments.

Connaissances

Lean Six Sigma

Project management

Change management

Manufacturing leadership

Communication skills

Analytical problem-solving

Formation

Bachelor's degree

Description du poste

Civica, Inc. in Petersburg, VA is seeking a Manager of Manufacturing, Vial Fill, to help startup and support daily operations, ensuring timely production of pharmaceuticals and quality injectables.

You will lead a manufacturing team, participate in equipment qualifications, drive Lean/Six Sigma initiatives, perform investigations and CAPAs, and assure compliance with FDA, cGMP, ISO and OSHA, with a flexible schedule to meet project milestones.