FFL Operations Supervisor

Proclinical is currently recruiting for an FFL Operations Supervisor with a pharmaceutical company located in Marietta, PA. As an FFL Operations Supervisor (3rd Shift), you will supervise under guidance from manager and higher level supervisory staff the aseptic buffer and vaccine formulation, vial filling lyophilizing, vial capping and vial inspection lines in secondary manufacturing operations to meet required quality, compliance and delivery targets of process validation lots and commercial products. Ensure manufacturing operations are executed in cGMP compliant manner and complies with company conformance standards and all applicable regulations. Manage the training and qualifications for staff to insure all operating procedures are followed and compliant with all company defined standards and federal regulations. Develop skills, supervise, lead and motivate a production team. This role will provide YOU the opportunity to lead key activities to progress YOUR career.

Job Responsibilities:

• Supervise manufacturing processes, automation equipment and personnel to ensure quality operations
• Proactively and continuously manage product risk and escalate risks through site management, consult with manager as needed
• Supervise the day to day activities of operations associates and Electro Mechanical Technicians performing aseptic buffer and vaccine formulation, filling, lyophilization, capping and inspection manufacturing operations
• Coordinate resources required to complete routine work and assigned special projects in a timely manner
• Manage manufacturing operations through SAP functions
• During active Technical Transfer projects, work with Local Team, Donor Site and Global Technology
• Assists with the development and implementation of productivity improvement plans using Industrial Excellence methodologies
• Monitor and report progress of safety objectives, performance against schedule and number of defects
• Identify the cause of the problems and continue to educate staff on solutions, accident avoidance and error reductions
• Work towards becoming an SME in the development and maintenance of simple, effective, visual LSOPs for Equipment and Areas
• Co-owner for Quality System Events related to aseptic formulation, filling, lyophilization, capping and inspection manufacturing operations
• Support the process for and troubleshoots process deviations and equipment failures
• Co-Responsible for activities in support of inspection readiness for the FFL Value Stream
• Manage safe and efficient operations of production areas by providing adequate training and routine inspections for all supervised personnel
• Perform all job responsibilities in compliance with applicable EHS and GMP regulations, guidelines, policies, standard operating & safety procedures, and industry practice and Industrial Excellence initiatives

Skills and Requirements:

• Bachelor's degree in a biological, chemical science, or engineering or equivalent technical discipline
• 3+ years experience in (Clinical Good Manufacturing Practices) cGMP environment

Preferred Qualifications:

• Prior pharmaceutical production experience in vaccines or biopharmaceuticals and in a role leading cross functional teams
• Preferred experience should include supervising and managing production including aseptic technique, filling, and lyophilization, product visual inspection, input to scheduling and planning and regulatory compliance
• Ability to delegate, train, evaluate, coach and discipline others is required
• In lieu of this experience, completing the graduate rotational program will be considered
• The position requires the ability to travel internationally 10% of the time
• Prior user experience with MS Project or similar project planning software
• The ability to quickly grasp and apply site policies and procedures and relate them to project scope
• Possess a technical understanding of industry and scientific principles and practices related to the business
• Full understanding of GMP's, and other applicable regulatory agency requirements with demonstrated success in application

If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at 267-846-2026. ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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