Sr. Sterility Assurance Engineer

2 weeks ago

Indianola, United States Bayer Full time
At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

Sr. Sterility Assurance Engineer - Indianola, PA

Sr. Sterility Assurance Engineer - Indianola, PA

PURPOSE

The Senior Sterility Assurance Engineer leads New Product and Change Control projects affecting product microbiology, sterilization, packaging, and biocompatibility. In addition, this role is responsible for maintenance of validations, investigations of non-conformances, driving corrective actions, and documentation of remedial actions. This role develops, validates and implements sterilization processes, directs the qualification of new products and existing products to meet biocompatibility, sterility, and microbiological requirements. The incumbent reviews and approves laboratory records and reports, as well as prepares test protocols, change control assessments, and test reports. The Senior Sterility Assurance Engineer presents data and information to management.

YOUR TASKS AND RESPONSIBILITIES
  • Plans and manages own work activities of significant technical scope with minimal direction;
  • Validates radiation and ethylene oxide (EO) sterilization processes;
  • Maintains sterilization process validations (quarterly dose audits, annual re validation of EO sterilization);
  • Collaborates with project teams on programs with potentially significant impact to the business;
  • Serves as SME in Microbiology / Biocompatibility / Sterility;
  • Testing for R&D or New Product Development projects;
  • Reviews sterilization process records;
  • Investigates and documents sterilization process non conformances and drives corrective actions;
  • Conducts data analysis, trending, and reporting to management;
  • Responsible for development and integration of policies and procedures (P&P);
  • Writes technical procedures, test protocols and reports;
  • Directs work of junior engineers, scientists, and technicians to support project deliverables;
  • Documents Change Control Assessments:
    • Biocompatibility Assessments;
    • Microbiological Baseline Assessments;
    • Sterilization Evaluations / Product Adoptions;
  • Other duties as assigned.

WHO YOU ARE

Bayer seeks an incumbent who possesses the following:

REQUIRED QUALIFICATIONS
  • Bachelor of Science in an engineering or scientific discipline;
  • Experience in medical device and/or pharmaceutical manufacturing, sterilization, microbiology, toxicology, validation, product development, or quality;
  • Demonstrated knowledge and application of engineering and scientific concepts within medical device and/or pharmaceutical manufacturing;
  • Handles multiple concurrent projects;
  • Understands priorities of assigned tasks and plans daily activities accordingly;
  • Develops creative solutions to challenging and novel problems under minimal direction;
  • Intermediate knowledge of other technical disciplines (engineering, quality assurance, R&D, regulatory).
  • Applies tools and technologies to complex problems typically involving a multidisciplinary approach;
  • Demonstrates analytical capabilities including statistical analysis and problem solving
  • techniques;
  • Able to write and apply relevant policies and procedures (P&P) based on regulations and industry standards;
  • Able to present technical concepts to laypersons and management;
  • Experience in Ethylene Oxide sterilization process development and validation; adoption of new products to existing processes;
  • Experience in Gamma / E beam sterilization process development and validation; adoption of new products to existing processes;
  • Demonstrated ability to work under minimal direction, lead teams, and coordinate disparate groups to achieve project goals;
  • Demonstrated understanding of biocompatibility and/or sterilization standards and regulatory requirements for medical devices.

PREFERRED QUALIFICATIONS
  • 4 to 7 years of experience in medical device and/or pharmaceutical manufacturing, sterilization, microbiology, toxicology, validation, product development, or quality;
  • Biocompatibility testing experience;
  • Understanding of radiation physics;
  • Knowledge of materials characterization and analytical chemistry techniques;
  • Experience with sterile barrier package design and validation per ISO 11607;
  • Certified Industrial Sterilization Specialist (CISS) accreditation.
YOUR APPLICATION
Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Science for a better life, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer.
To all recruitment agencies: Bayer does not accept unsolicited third party resumes.

Bayer is an Equal Opportunity Employer/Disabled/Veterans

Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

Bayer is an E-Verify Employer. Location: United States : Pennsylvania : Indianola Division: Pharmaceuticals Reference Code: 827819 Contact Us Email: hrop_usa@bayer.com

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