Vial Fill Manufacturing Lead — Lean & GMP

BioSpace; Petersburg (VA); On-site; USD 150,000 - 190,000; Full time

Job summary

BioSpace in Petersburg, VA seeks a Manager, Manufacturing, Vial Fill to lead the site start-up and oversee daily operations for injectable products. You will qualify equipment, drive process improvements, and mentor manufacturing staff to ensure safe, compliant, cost‑effective production aligned with Civica culture and patient focus.

The role demands 8+ years in cGMP environments, high‑speed fill/finish experience, expert facilitation, and strong project management with Lean/Six Sigma.

Qualifications

• 8+ years of demonstrated ability in a cGMP FDA, cGMP, ISO, or other regulated production environments.
• Advanced experience in a process improvement environment with project management and Lean/Six Sigma.
• Prior high-speed fill/finish (vial, cartridge, PFS) experience.
• Expert facilitation skills with demonstrated results.
• Ability to own and drive assigned projects across functions.
• Excellent oral and written communication skills.
• Self-directed with strong analytical and problem-solving abilities.

Responsibilities

• Actively participate in new equipment and process qualifications under direction.
• Develop and create SOPs, specs, and governing documents for manufacturing processes.
• Ensure operations meet production plans at minimum costs within quality and regulatory requirements.
• Identify opportunities to improve service, quality, safety, and cost using Lean Manufacturing and project management.
• Mentor Manufacturing Associates in statistical tools and Lean/Six Sigma methods.
• Use statistical tools to investigate deviations and perform root cause analyses.
• Lead CAPA projects to completion and verify effectiveness.
• Act as SME in manufacturing equipment and processes including aseptic filling and packaging.
• Maintain flexibility to meet project milestones and production demands.

Skills

Process improvement

Project management

Lean Six Sigma

Fill/finish experience

Facilitation skills

Cross-functional collaboration

Communication skills

Problem solving

Self-directed

Change management

Education

Bachelor's degree

Job description

BioSpace in Petersburg, VA seeks a Manager, Manufacturing, Vial Fill to lead the site start-up and oversee daily operations for injectable products. You will qualify equipment, drive process improvements, and mentor manufacturing staff to ensure safe, compliant, cost‑effective production aligned with Civica culture and patient focus.

The role demands 8+ years in cGMP environments, high‑speed fill/finish experience, expert facilitation, and strong project management with Lean/Six Sigma.