Job Description:
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. This position will provide new process training to the manufacturing team to achieve efficient, cost-effective, safe, and compliant production of high-quality injectable products in line with the Civica culture and vision for what is in the best interest of the patient. This is a 6:00 AM – 6:30 PM, 2-2-3 work schedule.
Essential Duties and Responsibilities:
- Under the Director of Manufacturing’s direction, actively participate in new equipment and process qualifications.
- Demonstrated ability to act as subject matter expert in manufacturing processes, including autoclaves, parts washers, clean-in-place (CIP), and material transfer isolators (MTIs).
- Serve as the escalation point for their group, take accountability and ownership for business, technical, and compliance decisions
- Maintain Civica’s right to operate:
- Maintain 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 ensure staff’s safety, product quality, and continuity of supply
- 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, process efficiencies, or otherwise reduce manufacturing costs by using effective project management, cost control techniques, and Lean Manufacturing tools and techniques.
- Mentors, coaches, and teaches Manufacturing Associates in the use of change management/control techniques to ensure timely completion of projects.
- Utilizes scientific methods and statistical tools to perform investigations, root cause analyses, and impact assessments in support of the timely resolution of deviations/discrepancies related to Manufacturing.
- Identifies corrective and preventive actions (CAPA) and leads projects to completion within project timelines. Verify the effectiveness of CAPA by post-project data collection and analysis.
- Demonstrated ability to act as subject matter expert in manufacturing processes, including autoclaves, parts washers, clean-in-place (CIP), and material transfer isolators (MTIs).
- Flex schedule to meet commitments and achieve milestones related to projects, production, and other demands of the role.
- Ability to work on-site is required
- Maintain accuracy of and approve staff’s timecards
Basic Qualifications and Capabilities:
- Bachelor's degree with 4+ years of demonstrated ability in a cGMP FDA, cGMP, ISO, or other regulated production environment. An associate’s degree and 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 here are representative of those required to perform the essential functions of this position. Reasonable accommodation may be made to enable individuals with disabilities to perform the functions.
While performing the essential duties of this position, the employee is regularly required to speak or hear. The employee is frequently required to use their hands or fingers, handle or feel objects, tools, or controls. The employee is 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.
The company is an Equal Opportunity Employer, drug free workplace, and complies with ADA regulations as applicable.