Vial Filling Process Owner Manager

Job Title: Vial Filling Process Owner 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. 

This is a 3rd shift position.

Manages process within a product team 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 recommendations for cost reductions, profit improvement opportunities, cost control, quality of product, incident investigations, managing departmental capital and operation's budgets. Also responsible for Quality Systems including deviation investigation and CAPA/Change Control implementation.

Additional responsibilities include determining and presenting technical process improvements and communicating issues to appropriate groups (e.g., IOC, 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.

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 with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?​

Main Responsibilities:

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

• 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

• 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 SGS meetings and proactively addresses observations

• 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:

• 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:

• Executes procedure 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

• Strong data analysis skills.

• 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

• Intermediate proficiency in MS Office Suite

• Working knowledge of SAP preferred

• Lean manufacturing preferred

Education:

• BS degree in Life Sciences or Engineering with 3-5 years relevant experience in manufacturing and/or filling of biological products

• 7+ years relevant experience in manufacturing and/or filling of biological products in lieu of degree

Experience Required:

• Must have previous experience in working with a production department of a pharmaceutical company.

• Experience in FDA Regulated Industry

• Working knowledge of cGMP's

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to gain experience and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take diligent care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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