Manufacturing and Supply
Wo Wunder der Wissenschaft
für Patient*innen Realität werden

Job title: B57 Environmental Monitoring Lead

Location: Switftwater, 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.

Our Team:

FFIP at Swiftwater produces over 100M doses for >10 drug products annually. The operation is a 24x7 production facility that includes formulation suites and cleanrooms with Filling RABS or Isolators. The environment is fast paced and a strong level of collaboration with support functions is expected in the achievement of operational goals. Our ambition is to be a flexible, well-trained operations team that utilized support functions to be a best-in-class facility. We strive to maintain a positive work environment while increasing capacity through continuous improvement.

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:

Provide the leadership, direction, and oversight of the Building 57 Environmental Monitoring Team which supports B57 Aseptic filling and formulation at the Swiftwater site.  This position is responsible for the Environmental monitoring team across three shifts seven days per week, including safety, quality, supply, and financial results. He or she provides guidance and is responsible for development of a team which includes managers and technicians that have the same focus. 

• Provide leadership and direction to B57 Environmental Monitoring Team to meet the established strategic vision of FFIP Areas in B57.  The Environmental Monitoring Lead is responsible to ensure the manufacturing facilities and equipment within his/her control are properly maintained.  The Lead manages ~20 team members across 3 shifts.  Ensures completion of all Daily, weekly, monthly and batch related environmental monitoring.  The team is responsible for assisting in EM related training and completion of annual EM PQs and requalifications of the environments.
• Provide leadership and direction to ensure Deviations, Change Controls, CAPAs, and regulatory commitments are met on time and with the highest standards of quality.  Ensure CAPA’s are effective and completed on time. Responsible for ensuring assigned areas meet current FDA, International Regulatory Body, and Corporate Quality requirements.  Participate in facility and process audits
• Responsible for working with Sterility assurance to complete the Critical Processing Parameters (CPPs) for B57 Aseptic Process Simulations (APSs) and tracking Aseptic technician and Operator APS qualification status, by working with the PCUs for each line, training and SA.
• Ensures all EM samples are entered into LIMS, ESum approvals/corrections are made to support release cycle times.

• Actively pursues the implementation of best industry practices on Environmental Monitoring, which includes evaluation of new/improved EM monitoring equipment or solutions and implementation of SMS 2.0 processes/ ways of working to drive performance and to support Filling and formulation operations.  Actively Participates and leads SMS meetings to ensure compliance with SMS standards.  Identify and ensure all required metrics and cycle times are maintained.

• Responsible for projects including providing assistance and recommendations regarding buildings, equipment, and processes relating to the integration of the manufacturing area.  Development of working relationships and strong communication links through all levels of the organization.  Provides day-to-day support for the production floor to support completion of short-term projects.

• Provides leadership and establishes departmental objectives to align with site vision for safety, quality, productivity, cost, continuous improvement, and employee involvement. Responsible for ensuring that all associates have what they need to complete their jobs safely.

• Builds and maintains a high performing team, providing effective alignment and communication with all teams at the site and at other manufacturing sites, to successfully deliver on all commitments. 

• Provide direction, evaluate and develop performance of direct reports

• Help in resolution of problems or introduction of changes in their respective areas

• Set performance standards and evaluate performance

• Provide career development and training advice and set short term and long term goals

• Provide regular feedback to direct reports on company and departmental operationsManages headcount and expenses in department to achieve site objectives and meet budget expectations…

About you

Basic Qualifications:

• 7+ years’ experience in a cGMP Aseptic manufacturing environment

• 3+ years leading teams

• Bachelor’s Degree in Life Sciences (e.g. Biology, Chemistry, Biochemistry) or Engineering (e.g. Chemical Engineering) preferred

• Strong understanding of Quality systems

Preferred Qualifications:

• Experience in an Aseptic manufacturing (cGMP) environment.

• Experience in managing multiple priorities in production environment and provide support to meet the manufacturing schedule while maintaining quality and compliance.

• Experience in inspections conducted by external regulators.

• Experience working with cross-functional teams, including Quality, Manufacturing Technical Services, Facilities, Engineering and Validation.

• Experience reviewing standard operating procedures, on-the-job-trainings, and other controlled documents.

• Experience troubleshooting, investigation (GPS), root cause and risk analysis in a cGMP environment..

• Ability to effectively and appropriately escalate operational issues.

Special Working Conditions:

• Ability to gown for entry to Aseptic  manufacturing areas.

Soft skills:

• Leadership, Communication, Decision making, Conflict Management/Resolution, Employee/Team Development

Technical skills:

• Business Analysis, Scheduling/Planning, Budget/Headcount Management, Process Improvement

Experience:

• Must have 5 years of experience in aseptic clean room operation to including environmental monitoring.
• Thorough knowledge of cGMP and regulatory requirements in addition to experience working in controlled/pharmaceutical industry or regulated quality environment is required. 
• Must have previous experience leading teams.

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent 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 good 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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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.