Filling Aseptic Process Manager- Vaccines

Job Title: Filling Aseptic Process Manager

Location: Swiftwater, PA

About the Job

We deliver 4. 3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Responsible for overseeing process, personnel and activities associated with assigned PCU and shift, ensuring team adherence to all +QDCI standards. Drive continual improvement of line and team performance through leading and supporting projects and initiatives including investigations into deviation from planned outcome and associated CAPA to prevent reoccurrence.

This role is for an exempt employee working in the Filling Department. Their Bi-weekly pay is based on previous experience and education time.

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

Main Responsibilities:

Context of job/major challenges:

• Manages the process within the shift to meet goals and priorities. Assures operations are conducted in compliance with regulatory authorities. Assures operations are conducted in compliance with cGMPs, CBER, WHO, EP and other regulatory bodies.

• Plans and initiates the overall production schedules and coordinates personnel activities with other manufacturing staff.

• Reviews batch records for correctness and completeness.

• Overall responsibilities include employee selection, training, development, counseling recommendations for cost reductions, profit improvement opportunities, cost control, quality of product, incident investigations, managing departmental capital and operation's budgets.

• Involves providing managerial coverage for employees as required during assigned shift hours.

• Additional responsibilities include determining and presenting technical process improvements and communicating issues to appropriate groups (e. g. , Management Committee, staff meetings), and work unit teams. When necessary, coordinates Maintenance, Metrology, and Validation activities with applicable leaders.

• Takes a role in implementing new equipment and procedures.

• Performs all other duties as required by department management. Deviation management, people development, and Quality Assurance of the Aseptic Processing area are required. Background in Aseptic Processing is favorable.

Their responsibilities are, but are not limited to:

Safety:

• Follows all procedures put into effect to ensure your safety as well as the safety of others. Participates in monthly safety meetings

• LSVs and MSVs

• Reports all safety issues, concerns, incidents and near misses to the team leadership

• Actively participates in safety walkthroughs coordinated by the department's safety team

• Provides input for potential safety issues as well as contributing ideas for corrective and preventative actions including the support of Safety improvement initiatives and investigations.

• Follows effective procedures to ensure the production of a safe and efficacious product.

• Utilizes +QDCI boards for Safety issues

Quality:

• Regulatory audit understanding and awareness. Point of contact for training discussions for regulatory and internal inspections

• Assures that operations are conducted in compliance with cGMPs, CBER, WHO, EP and other regulatory bodies

• Supports 5W2H's and deviation meetings to proactively addresses observations. Lead and support investigational teams to complete investigations and develop sound CAPA to prevent reoccurrence.

• Conducts real time reviews to assess aseptic performance, GMP data entries, and all metrics are accurately updated

• Understands the function of the quality group and works with them to maintain a positive rapport.

Delivery:

• Perform data review and analysis to identify and drive initiatives and projects to continuously improve line performance working closely with CI Specialist, Reliability engineering and Asset care.

• Supports production in accordance with volume fluctuation, business need, and effective procedures. Must be flexible to ensure staffing for changing business volume and needs.

• Follows escalation procedures to mitigate any variables negatively impacting eOOE.

• Reviews eOOE metrics throughout shift to ensure proper categorization of downtime.

• Ensure training of personnel is assigned and entered as needed in order to support business needs.

• All other duties as assigned. Adheres to all other company time keeping and attendance policies.

Cost:

• Drives CI and cost reduction initiatives

• Executes procedures as documented to avoid deviations.

• Ensure training methodologies are implemented to improve operator efficiencies.

• Supports all changeover related functions to achieve eOOE standard.

Involvement:

• Works to become trained in all assigned training modules.

• Trains and orients new team members (at any level) as assigned.

• Participates and leads team meetings. Understands respect, professionalism and confidentiality.

• Ensures Training coordinator / Trainers, train and guide personnel in proper work procedures, use of equipment, cGMP's, safe work techniques, and SAP to assure timely signoffs and consistency in training. Maintains qualified trainer status.

All other duties as assigned.

About You

Education/Experience:

• Must be very detail-oriented and organized with excellent time-management skills

• Strong analytic and problem-solving abilities, as well as the flexibility to change and adapt as the job grows and develops

• Excellent verbal and written communication, interpersonal and presentation skills, as well as the ability to interact tactfully and effectively with employees at all levels of the organizational structure.