Supervisor, Manufacturing Support - 2/2/3 Days (580)
About the role
The Manufacturing Support Supervisor will play a role in facility start‑up and commercialization, supporting daily manufacturing operations and the timely production of pharmaceuticals at the Civica site in Petersburg, VA. The supervisor will hire, develop, and support a team of manufacturing associates through equipment qualifications, process improvement, equipment operation, and documentation ownership. The role also provides new‑process training to achieve efficient, cost‑effective, safe, and compliant production of high‑quality injectable products in line with Civica’s culture and patient‑focused vision.
Responsibilities
- Actively participate in new equipment and process qualifications under the Director of Manufacturing’s direction.
- Serve as subject‑matter expert for manufacturing processes, including autoclaves, parts washers, clean‑in‑place (CIP) systems, and material transfer isolators (MTIs).
- Act as the escalation point for the group, taking accountability for business, technical, and compliance decisions.
- Maintain Civica’s right to operate by ensuring inspection readiness and serving as SME during inspection tours.
- Ensure staff are appropriately trained and qualified before executing activities.
- Oversee systems and processes to guarantee staff safety, product quality, and continuity of supply.
- Develop and maintain standard operating procedures, specifications, and other governing documents that delineate manufacturing process requirements.
- Ensure manufacturing meets approved production plans at minimum cost while complying with FDA, cGMP, ISO, and OSHA requirements.
- Identify opportunities to improve customer service, quality, safety performance, process efficiency, or reduce manufacturing costs using project‑management, cost‑control, and Lean Manufacturing tools.
- Mentor, coach, and teach Manufacturing Associates in change‑management and control techniques to ensure timely project completion.
- Utilize scientific methods and statistical tools to conduct investigations, root‑cause analyses, and impact assessments for deviations and discrepancies.
- Identify corrective and preventive actions (CAPA), lead CAPA projects to completion, and verify effectiveness through post‑project data collection and analysis.
- Maintain a flexible schedule to meet project milestones, production demands, and other role commitments.
- Work on‑site as required and maintain accuracy of, and approve, staff timecards.
Qualifications
- Bachelor’s degree with 4+ years of experience in a cGMP‑regulated production environment (FDA, cGMP, ISO). An associate’s degree with 6 years of cGMP production experience may be considered.
- Experience with autoclaves and parts washers.
- 1+ year of supervisory experience in a GMP manufacturing environment.
- Experience in process‑improvement environments, including change management and leading teams.
- Lean Manufacturing or Six Sigma Green Belt certification preferred.
- Strong writing and documentation skills.
- Self‑directed with effective analytical and problem‑solving abilities.
- Strong interpersonal, collaboration, communication, and leadership skills.
Schedule
6:00 AM – 6:30 PM, 2‑2‑3 work schedule.
Physical Demands
The role requires regular speaking and hearing, frequent use of hands or fingers, and handling of objects, tools, or controls. The employee is occasionally required to stand, walk, sit, and reach with hands and arms, and may need to lift or move up to 40 pounds. The work environment’s noise level is usually low to moderate.