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, with primary responsibilities focused on supporting daily manufacturing operations and the timely production of pharmaceuticals at the Civica site in Petersburg, VA. This position will hire, develop, and support a team of manufacturing associates through equipment qualifications, identifying and improving processes, operating manufacturing equipment, and owning documentation. The supervisor will provide new process training to achieve efficient, cost‑effective, safe, and compliant production of high‑quality injectable products in line with the Civica culture and vision for the best interest of the patient.

Responsibilities

• Actively participate in new equipment and process qualifications under the Director of Manufacturing’s direction.
• Serve as subject matter expert in manufacturing processes, including autoclaves, parts washers, clean‑in‑place (CIP), and material transfer isolators (MTIs).
• Act as the escalation point for the group, taking accountability and ownership for business, technical, and compliance decisions.
• Maintain Civica’s right to operate; ensure inspection readiness and serve as SME during inspection tours.
• Ensure staff are appropriately trained and qualified for the activities they perform prior to execution.
• Ensure systems and processes are properly executed and maintained to protect staff safety, product quality, and continuity of supply.
• Develop and create standard operating procedures, specifications, and other governing documents to delineate manufacturing process requirements.
• Ensure the manufacturing organization meets approved production plans at minimum cost within established quality limits and in accordance with FDA, cGMP, ISO, and OSHA requirements.
• Identify opportunities to improve customer service, quality, safety performance, process efficiencies, or reduce manufacturing costs using effective project management, cost‑control techniques, 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 perform investigations, root‑cause analyses, and impact assessments for deviations/discrepancies.
• Identify corrective and preventive actions (CAPA), lead projects to completion within timelines, and verify effectiveness through post‑project data collection and analysis.
• Flex schedule to meet commitments and achieve milestones related to projects, production, and other role demands.
• Ability to work on‑site is required.
• Maintain accuracy of and approve staff’s timecards.

Qualifications

• Bachelor’s degree with 4+ years of demonstrated ability in a cGMP FDA, cGMP, ISO, or other regulated production environment (an associate’s degree with 6 years of cGMP production experience may be considered).
• Experience with autoclaves and parts washers.
• 1+ years of supervisory experience in a GMP manufacturing environment.
• Experience in a process‑improvement environment, including change management and leading teams.
• Lean Manufacturing/Six Sigma Green Belt certification preferred.
• Strong writing and documentation skills.
• Self‑directed with effective analytical and problem‑solving skills.
• Strong interpersonal, collaboration, communication, and leadership skills.

Physical Demands and Work Environment

The physical demands described are representative of those required to perform the essential functions of this position. While performing the essential duties, the employee is regularly required to speak or hear, frequently required to use hands or fingers, handle or feel objects, tools, or controls, and occasionally required to stand, walk, sit, and reach with hands and arms. The employee must occasionally lift and/or move up to 40 pounds. The noise level in the work environment is usually low to moderate. Reasonable accommodation may be made to enable individuals with disabilities to perform the functions.

Schedule

6:00 AM – 6:30 PM, 2‑2‑3 work schedule.