Manufacturing Manager - Vial Line 1st Shift

Civica Rx•Petersburg, VA

About The Position

The Manager, Manufacturing, Vial Fill, supports the facility start-up and daily manufacturing operations at Civica’s Petersburg, Virginia site, with a focus on timely pharmaceutical production. The role develops and supports the Manufacturing team, participates in equipment qualification, identifies and implements process improvements through monitoring, and conducts investigations and impact assessments. The manager leads the team in producing quality injectable products efficiently, cost-effectively, safely, and in compliance with applicable requirements, consistent with Civica’s patient-focused culture and vision. The position reports to the Director of Manufacturing’s direction for participation in new equipment and process qualifications. It creates governing documents, ensures production meets plans and quality limits, leads improvement and CAPA projects, and serves as a subject matter expert in manufacturing equipment and processes, including aseptic filling, isolator/RABS technology, and packaging. A flexible schedule is required to meet project, production, and other role commitments.

Requirements

Bachelor’s degree and 8 or more years of demonstrated ability in cGMP FDA, cGMP, ISO, or other regulated production environments; equivalent education and experience may be considered.
Prior high-speed fill/finish experience, such as vial, cartridge, or prefilled syringe production.
Expert facilitation skills with demonstrated results.
Ability to interact with other functions and take ownership of and follow through on assigned projects.
Excellent oral and written communication skills.
Self-directed, with effective analytical and problem-solving skills.
Ability to gown according to site procedures and work in controlled manufacturing environments.
Ability to occasionally lift and/or move up to 40 pounds.

Nice To Haves

Lean/Six Sigma certification.

Responsibilities

Participate in new equipment and process qualifications under the Director of Manufacturing’s direction.
Develop standard operating procedures, specifications, and other governing documents that define manufacturing process requirements.
Ensure Manufacturing operations meet approved production plans at minimum cost, within quality limits, and in accordance with FDA, cGMP, ISO, and OSHA requirements.
Identify opportunities to improve customer service, quality, safety, performance, and scrap minimization, or to reduce manufacturing costs, using project management, cost control, and Lean Manufacturing techniques.
Mentor, coach, and teach Manufacturing Associates to use statistical tools, Lean/Six Sigma methodologies, and change management/control techniques.
Use scientific methods and statistical tools to conduct investigations, root cause analyses, and impact assessments for manufacturing deviations and discrepancies.
Identify corrective and preventive actions (CAPA) and lead projects to completion within established timelines.
Verify CAPA effectiveness through post-project data collection and analysis.
Serve as a subject matter expert in manufacturing equipment build and function and manufacturing processes, including aseptic filling, isolator/RABS technology, and packaging.
Flex the work schedule to meet project, production, and other commitments.