Manager - Manufacturing Cartridge Line (429)

Civica Rx • Petersburg, VA

8d

About The Position

The Manager, Manufacturing, Cartridge Line 1 st Shift will play a part in the facility start-up, with primary responsibilities focused on supporting daily manufacturing operations and the timely production of pharmaceuticals at the Civica Petersburg, VA site. The Manager will develop and support the Manufacturing team by participating in equipment qualifications, identifying and implementing process improvements through process monitoring, conducting investigations, and impact assessments. Will provide new process training to the manufacturing team to achieve efficient, cost-effective, safe, and compliant production of quality injectable products according to the Civica culture and vision of what is in the best interest of the patient. In collaboration with stakeholders, this position will lead day-to-day Manufacturing Cartridge Fill Line responsibilities on the 1st shift, overseeing and running all equipment, supporting new product introductions, equipment qualifications, change management, investigations, training, and development. The ideal candidate will have a consistent track record of achieving results in a fast-paced Pharmaceutical Sterile Fill/Finish environment.

Requirements

• Bachelor's degree with 8+ years of demonstrated ability in a cGMP production environment. An Associate’s degree and 10 years of cGMP production experience may be considered.
• Experience in a sterile fill-finish facility.
• 3+ years’ supervisory experience in a GMP manufacturing environment.
• Strong writing and documentation skills.
• Strong interpersonal, collaboration, communication, and leadership skills.
• Experience in a process improvement environment, including change management, optimizing process flow, and participating in Lean/Six Sigma project teams.
• Self-directed with effective analytical and problem-solving skills.
• Interact with other functions and must be able to take ownership of and follow through on assigned projects.

Responsibilities

• Under the Director of Manufacturing’s direction, actively participate in new equipment and process qualifications.
• 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, scrap minimization, or otherwise reduce manufacturing costs by using effective project management, cost control techniques, and Lean Manufacturing.
• Mentors, coaches, and teaches Manufacturing Associates in the use of statistical tools, Lean/Six Sigma methodologies, and change management/control techniques to ensure timely completion of projects at the expected results.
• Utilizes scientific methods and statistical tools to perform investigations, root cause analyses, and impact assessments in support of timely resolution of deviations/discrepancies related to Manufacturing.
• Identify corrective and preventive actions (CAPA), lead project 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 equipment build and function, as well as in manufacturing processes, including aseptic filling, isolator/RABs technology, and packaging.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager