Principal Quality Aseptic Specialist

Additional Location(s):  N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.                

Principal Quality Aseptic Specialist
 

About This Role:
 

At Boston Scientific, the Principal Quality Aseptic Specialist will oversee aseptic manufacturing processes to ensure compliance to 13408, GMP review intervention resolutions, approve plans for improvements, and advise site leadership on aseptic operations.

In a fast-paced and dynamic environment, the Principal Quality Aseptic Specialist will be responsible for partnering with Production, Engineering, R&D, and Microbiology teams to prioritizing quality signals and improvement projects to ensure the manufacture and delivery of high-quality aseptic products and facilitate compliance with regulatory requirements.

 

Your Responsibilities Include:
 

• Own and drive deliverables related to site Contamination Control Strategy for Aseptic product manufacturing.
• Provide guidance and training to Operations team on aseptic processing, including development of internal training on key aspects related to aseptic manufacturing, cleanroom behaviors and aseptic processing in biological safety cabinets and isolator systems.
• On the floor support model to drive partnership with operations to enhance bio-decontamination prevention and control, monitor and support aseptic Process Simulations Media Fills.
• Oversee Extractible and leachable studies / Antimicrobial effectiveness testing / Elemental impurities.
• Manage technical queries from vendors and regulatory bodies and inform strategies concerning submission.
• Manage responses and closure of RFI’s from regulators by directing and coordinating site responses and authoring justifications where relevant.
• Support new product and process integrations with built in quality and strategies that align to production area.
• Maintain and enhance cross-functional and cross-site relationships.
• Provide guidance regarding technical strategies and approaches; work cross-functionally in identifying and resolving technical issues.
• Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Monitor and ensure compliance with company policies and procedures (e.g., federal/country, and regulatory requirements).

 

What We're Looking For: 
 

Required Qualifications:
 

• Minimum of a bachelor's degree in scientific discipline with 10+ years of cGMP experience in a relevant Microbiological role preferably in an aseptic environment or supporting aseptic manufacturing 
• Good working Knowledge of the US and EU GMP and Safety Compliance regulations, e.g., Annex 1
• Knowledge of Isolator formulation and filling systems and VHP decontamination, single use technology, primary packaging components (sing dose syringe, caps, sealed package)

Preferred Qualifications:
 

• Advanced technical degree preferred.
• Previous experience interacting with Regulatory agencies. 
• Effective communication skills demonstrated track record of project management execution, and leadership experience.
• Medical device experience
   

Requisition ID: 582038

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

 

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

 

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and oppor