Job Details

Base pay range

$74,250.00/yr - $123,750.00/yr

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 position is responsible for providing Quality & Compliance oversight to site validation projects related to Drug Substance and/or Drug Product Vaccine manufacturing.

Main Responsibilities

• The individual would be part of the Site Quality Organization and will participate in project teams involved in site biotech facilities, processes and equipment for the manufacture of Drug Substance and/or Drug Product Vaccines and will review and approve validation related studies for assigned areas.
• These assigned areas would include validation lifecycle activities such as Validation Planning, Biotech Process Validation, Equipment and Facility Qualification and Validation Risk Management.
• This position has signatory responsibilities for validation/qualification documents within assigned areas.
• Candidates should have some knowledge in biotech manufacturing processes (i.e. viral antigen or formulation production).
• Excellent communication skills and teamwork are a must, as individual will be working on cross functional project teams which include members from various organizations within Sanofi Pasteur such as Manufacturing Technology, Engineering and Regulatory Affairs.
• Good interpersonal and influencing skills are important for a candidates success in this role.

Basic Qualifications

• Bachelors degree in Engineering, Science, or related field with 5+ years' experience preferably in a cGMP environment.
• Strong knowledge of cGMP regulations and quality standards applicable to pharmaceutical manufacturing.
• Proficient in relevant computer systems and software used in validation and quality management (e.g., LIMS, TrackWise, SAP).
• Ability to effectively communicate technical information to diverse stakeholders, including technical and non-technical audiences.

Benefits

• 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 its through a promotion or a 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.

Equal Opportunity

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, marital status, domestic partnership or civil union status, sex, gender, gender identity or expression, sexual orientation, disability, veteran or 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.