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Microbiologist - Perm Role Job

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Date: Oct 16, 2021

Location: Cork, C, IE

Company: Boston Scientific

Additional Locations:

 

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - 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.

At Boston Scientific, we draw the strength from the unique talents and abilities inherent in a diverse workforce and we believe that the best and most innovative products come from an inclusive workplace where varied viewpoints are welcomed and encouraged. If you require accommodation during the recruitment process please do not hesitate to contact a member of the Talent Acquisition team for a confidential discussion.

Purpose

 

Responsible for supporting the establishment, validation, qualification and ongoing support of pharmaceutical cleanroom and all associated test programs. To provide expert microbioloigcal support in the establishment of the Contamination Control Strategy and ongoing support to Operations, in ensuring operational goals and objectives are achieved for the plant. The Microbiologist will play a key part in establishing, maintaining, and enhancing the Microbiological monitoring programs developed to ensure the sterility assurance of the product.  

 

Responsibilities

 

  • Author, review and approve microbiological procedures, protocols and reports for establishment of pharamaceutical Microbiological monitoring programs to cGMP requirements. Support validation and engineering qualification activities. (e.g cleaning validation)
  • Ensure Regulatory compliance in area of responsibility to cGMP’s of all medical device regulatory agencies (e.g. FDA and HPRA).
  • Provide key support and technical expertise to the site to ensure people and technical skills are in place to implement new technologies and apply best practice in Microbiological techniques and systems.
  • Support development of the site strategy for cleanroom behaviours, aseptic practices and training of personnel.
  • Take the lead and provide direction in all areas relating to the sterility assurance of the product.
  • Responsible for microbiological systems and associated documentation, ensuring they remain current and in compliance to regulatory standards and Corporate requirements.
  • Provide functional expertise to other support functions on quality related issues (e.g. regulatory requirements, statistical techniques, sampling principles).
  • Establishes and cultivates a wide range of business relationships to facilitate completion of assignments. Participates in determining goals and objectives for projects.
  • Evaluate quality events ensuring compliance with cGMP and quality standard requirements. Support root cause analysis, product impact assessments and corrective and preventative actions (CAPAs) for quality events. Ensure timely and effective actions are implemented and that CAPA effectiveness checks are conducted.

 

 

Requirements

  • Third level qualification in Microbiology or related discipline.
  • Ideally 3-5 years experience within a pharmaceutical GMP environment.
  • Excellent interpersonal and communication skills with good leadership abilities.
  • Strong Decision-making skills and ability to work on one’s own initiative.
  • Ability to work with minimum supervision.

 

Perferred Qualifications

 

  • Experience in the pharmaceutical industry and GMP manufacturing with specific experience in the Microbiology function.
  • Working knowledge and understanding of FDA, HPRA, and the pharmaceutical industry microbiological requirements and associated manufacturing controls.
  • Experience in problem solving and process improvement methodologies
  • Process Validation, Risk Management, CAPA experience

 

 

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 opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

 

 


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