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Sterility Assurance Expert / QC Microbiology Lead

  • GE Healthcare
  • Experienced
  • Posted 10/27/2017 11:31:55 AM
  • 2998553
  • Job Function: Manufacturing
  • Business Segment: Healthcare Quality
Location(s): Netherlands; Eindhoven


About Us:
GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.


GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE works on things that matter - great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients.
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GE is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, and according with all local laws protecting different status.

Follow us on Twitter, join our LinkedIn Group or become a fan of our Facebook page. Receive job and event notifications by becoming a member of the GE Talent Community. Stay up to date on what’s happening at GE around the globe by checking out the GE Careers Blog.

Role Summary:
You will be responsible for managing the Sterility Assurance Program for aseptic manufactured and terminally sterilized drugs. You will serve as the key point of contact representing sterility assurance on various projects, change controls and investigations and will be a technical lead (SME) representing the Sterility Assurance Program within GE Healthcare B.V. during regulatory audits. In addition, this person will lead the QC microbiology team.

Essential Responsibilities:
Key responsibilities include:

  • Drives and is accountable for operational excellence of assigned program(s), with duties including project reviews, feasibility analysis, prioritization, initiation,
    execution and closure for all project work related to the sterility assurance program
  • Manages and supports implementation and maintenance of sterility assurance program and procedures for aseptically manufactured and terminally sterilized
    drugs
  • Develops and maintains a compliant sterility assurance program to comply with applicable company and worldwide regulatory requirements, including writing
    procedures
  • Oversees all aspects of sterility assurance functions which includes sterilization, bioburden control, sanitization and environmental monitoring programs
  • Acts as sterility assurance lead on projects for the implementation of new manufacturing lines or modifications to current manufacturing lines
  • Analyses data and implements process improvements related to microbiology/sterility assurance. This includes identification and implementation of new equipment and technologies and methods in the area of microbiology/sterility assurance
  • Manages process simulation program for aseptic drug manufacturing
  • Manages container closure integrity program for drug products
  • Reviews and approves Change Controls, SOPs, Deviations, CAPAs, Specifications and OOS investigations related to sterility assurance
  • Supports activities related to qualification/verification of sterilization methods
  • Performs internal audits for sterility assurance to comply with requirements of the program
  • Manages and continuously improves the sterility assurance training programs
  • Leads sterility failure and other high impact investigations related to sterility assurance to ensure root cause is determined in a timely manner and corrective and preventative actions are implemented
  • Supports QP's in batch sentencing decisions related to product sterility
  • Assists in vendor audits/assessments to ensure sterility assurance requirements are met
  • Manages the disinfectant efficacy and cleaning validation program for the site
  • Maintains effective working relationships with peers and other departments to ensure a robust sterility assurance program
  • Ensures the timeliness of testing microbiological samples
  • Participates and leads qualification and validation of QC micro equipment/ processes
  • Provides leadership and coaching to the QC Microbiology team (~ 6 FTE)
  • Coaches the QC microbiology team on the tools and practices required to drive day-to-day processes


Qualifications/Requirements:
Quality specific goals:
  • Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations
    as they apply to this job type/position
  • Complete all planned Quality & Compliance training within the defined deadlines
  • Identify and report any quality or compliance concerns and take immediate corrective action as required
  • Develop an open quality culture within the organization that fosters issue discussion and decision-making based on quality and compliance objectives

Qualifications:
  • Minimum Bachelor’s degree in Life Sciences such as Pharmaceutical Sciences, Microbiology, Biomedical Sciences, Biology, Food technology plus proven working experience and knowledge of sterile product manufacturing, quality control and sterility assurance
  • Demonstrated experience in a variety of microbiological methods
  • Demonstrated experience in project/risk management
  • Process improvement experience, knowledge of continuous improvement methodologies & in-depth understanding of related processes
  • Demonstrated effective interpersonal, teamwork, networking skills, collaboration, negotiation & conflict resolution skills
  • Ability to make decisions under pressure and take ownership for assigned projects and programs
  • Analytical, problem solving & root-cause analysis skills
  • Ability to handle multiple tasks with competing priorities effectively
  • Strong communication skills in English and Dutch (verbal & written)
  • Ability to interface and influence at all levels in the organization
  • Strong organizational skills
  • Prior experience using word processing, spreadsheet, and presentation software


Desired Characteristics:
Preferred qualifications:
  • Demonstrated experience & knowledge with regulations in the pharmaceutical industries
  • Some experience in leading and developing a team
  • Proven managerial/leadership skills such as work planning & evaluating
  • Change agent with energy, passion & enthusiasm to drive change
  • Experience in validation and qualification processes


Locations: Netherlands; Eindhoven

GE offers a great work environment, professional development, challenging careers, and competitive compensation.  GE is an Equal Opportunity Employer.  Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
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