Associate Engineer - QC Microbiology - Indianola, PA

Bayer•Indiana Township, PA

14d•$64,480 - $96,720

About The Position

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. Associate Engineer - QC Microbiology - Indianola, PA Associate Engineer for Bayer Medical Devices - QC Microbiology – Indianola, PA PURPOSE The Associate Engineer for Medical Devices QC Microbiology supports the sterilization and microbiology process for multiple Bayer manufacturing sites. The role is responsible for maintenance of validations, investigations into non-conformances, driving corrective actions, and documentation of remedial actions. The incumbent reviews and approves laboratory records and reports, as well as prepares test protocols, change control assessments, and test reports. The Associate Engineer works independently on projects with the support of other senior scientists and engineers.

Requirements

Bachelor of Science in engineering or scientific discipline required (e.g. Microbiology, Chemistry, Biomedical engineering, etc.);
Demonstrated knowledge and application of engineering and scientific concepts;
Must be proactive, ambitious and driven;
Must be capable of handling multiple concurrent projects while understanding the priorities of the assigned tasks and planning daily activities accordingly;
Demonstrates analytical capabilities including statistical analysis and problem-solving techniques. Develops creative solutions to novel problems under minimal direction;
Ability to write technical documentation in a logical manner that is clearly understood by personnel outside of the QC microbiology department;
Attention to detail is critical in this role;
Demonstrated ability to simplify and explain complex topics to others;
Proficient in Microsoft applications (Word, Powerpoint, Excel, etc.) and Statistical applications (Excel, MiniTab, etc.);
Demonstrated ability to research new topics and develop competencies through self-learning.

Nice To Haves

Experience and knowledge of the following topics is preferred but not required:
Microbiology;
Sterilization;
Biocompatibility;
Analytical Chemistry;
Cleanroom validation and operation;
Quality Control.
Certification related to the following topics is preferred but not required:
Certified Industrial Sterilization Specialist (Radiation and/or EO);
Biocompatibility specialist;
Cleanrooms;
Auditing.

Responsibilities

Plans and manages own work activities of minor technical scope under the supervision of senior scientists and engineers;
Assists with the maintenance of radiation and EO sterilization validations (quarterly dose audits, annual reviews);
Collaborates cross functionally on projects to determine the impact of changes to microbiology, sterilization and biocompatibility;
Reviews sterilization records;
Investigates and documents sterilization process non-conformances and drives corrective actions;
Conducts data analysis and trending;
Writes technical procedures, test protocols and reports;
Assists supplier quality with audits of key sterilization, microbiology and biocompatibility suppliers;
Supports requalification of medical device cleanrooms by reviewing and evaluating cleanroom data;
Attends training sessions and further develops capabilities and knowledge surrounding sterilization, microbiology, biocompatibility and cleanroom operation and validation;
Other duties as assigned.