Syringe Filling PCU Lead

Sanofi; Swiftwater (Monroe County); On-site; USD 130,000 - 190,000; Full time

Job summary

Sanofi in Swiftwater, PA seeks a Syringe Filling PCU Lead to oversee Line 7 operations, safety, quality, and performance across 3 shifts.

Lead a 35–45 person team, ensure deviations, CAPAs, change controls, and regulatory commitments are met while driving OEE improvements and cost controls. You will develop leaders, partner with QA and maintenance, upholding cGMP standards.

Qualifications

• Minimum: High School Diploma with 7+ years in a cGMP aseptic manufacturing environment and 3+ years leading teams.
• Preferred: Bachelor’s degree in business, engineering, life sciences or related fields with 3+ years in a cGMP aseptic manufacturing environment and 1+ year leading teams.
• Strong understanding of Quality systems
• Strong knowledge of cGMP and regulatory requirements
• Experience working in controlled/pharmaceutical industry.

Responsibilities

• Provide leadership to Line 7 Syringe Filling PCU across 3 shifts.
• Ensure Deviations, Change Controls, CAPAs, and regulatory commitments are met on time.
• Work with QA and Maintenance to address issues in real time.
• Drive OEE improvements and reduce operational costs under Line 7.
• Manage headcount and expenses to meet site objectives.

Skills

Leadership

Regulatory knowledge

cGMP knowledge

Team leadership

Quality systems

Education

High School Diploma

Bachelor’s degree

Job description

Job Title: Syringe Filling PCU Lead

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.

About Sanofi

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives.

Main Responsibilities

Provide the leadership, direction, and oversight of the Line 7 Syringe Filling PCU for B57 Aseptic filling at the Swiftwater site. This position is responsible the 24-hour performance (across all shifts) of the operating unit and team, including safety, quality, supply, and financial results. He or she provides guidance and is responsible for development of a team of managers that have the same focus area.

Team will meet the established strategic vision of FFIP Areas in B57. This Deputy Director is responsible to ensure the manufacturing facilities and equipment within his/her control is properly maintained. The PCU Lead manages ~35-45 team members across 3 shifts.In addition, this position will verify the continued validated state of all equipment and processes within their assigned area of responsibility.

• Provide leadership and direction to Line 7 Syringe Filling Process Centric Unit (PCU)
• Provide leadership and direction to ensure Deviations, Change Controls, CAPAs, and regulatory commitments are met on time and with the highest standards of quality. Responsible for ensuring assigned areas meet current FDA, International Regulatory Body, and Corporate Quality requirements. Leads audits from an operation side for facilities and process audits
• Provide direction and oversight for the shop floor and is accountable to ensure the highest safety and quality standards are maintained.Work closely with QA and Maintenance to ensure all issues are addressed real time. Develop effective cross functional relationships to support PCU goals and activities.
• Actively pursues the implementation of best industry practices on Aseptic Processing and implementation of SMS 2.0 processes/ ways of working to drive performance and to increase Filling OEE, improve unit operations success rate and reduce operational costs under the influence of Line 7. Actively Participates and guides Asset Care/CI /Deviation meetings to ensure compliance with SMS standards. Identify and ensure all required metrics and cycle times are maintained.
• Responsible for special 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 functional groups 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 operations
• Manages headcount and expenses in department to achieve site objectives and meet budget expectations.

About You

Basic Qualifications

Education/experience

• Minimum: High School Diploma with 7+years’ experience in a cGMP Aseptic manufacturing environment and 3+ years of experience leading teams.
• Preferred: Bachelor’s degree in business, Engineering, Life Sciences or related Fields with 3+years’ experience in a cGMP Aseptic manufacturing environment and 1+ years of experience leading teams.
• Strong understanding of Quality systems
• Strong knowledge of cGMP and regulatory requirements
• Experience working in controlled/pharmaceutical industry.

Soft skills

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

Technical skills

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

Preferred Qualifications

• 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 excellence, MSAT, 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 elevate operational issues.

Special Working Conditions

• Ability to gown for entry to Aseptic manufacturing areas.

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 andwellness programs and at least 14 weeks’ gender-neutral parental leave.
• Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
• Power industry-leading performance by leveraging digital, data, and AI-driven innovation – at speed and scale
• Transform lives worldwide by delivering life-changing treatments anywhere, anytime.

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.