Microbiologist II

Boehringer Ingelheim

Barceloneta, PR

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JOB DETAILS
LOCATION
Barceloneta, PR
POSTED
2 days ago
Description


Responsible of performing microbial tests for water samples, environmental samples, raw materials, in process and finished goods products when required following written procedures. This include calculate and report results as obtained by testing procedures and complete any deviation if apply. Develop and/or execute special microbiology studies, method verifications and protocols. Provide technical support and actively participate in the personnel certification for microbiology sampling. In the absence of the microbiology supervisor, the incumbent could assume supervisory responsibilities on a temporary basis. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.


Duties & Responsibilities


+ Performs microbiology tests according to establish procedures.

+ Report or verify results timely.

+ Acts as investigator or reviewer on deviations as assigned.

+ Performs purchases and maintains inventory of materials and reagents.

+ Assures the proper calibration and preventive maintenance of the laboratory equipment.

+ Develops, executes, and/or reviews applicable procedures and/or validation protocols or special studies.

+ Participates in the training and development program for new microbiologists.

+ Actively participate in the personnel certification program for environmental sampling in the areas.

+ This includes provide training, visit the areas to observe practices and trained personnel in correct aseptic practices.

+ Complies with all environmental guidelines, procedures, training, practices, permit conditions, and internal notification of any environmental events.

+ Segregates, performs inspection, labeling and handling of wastes such as biomedical, non-hazardous and hazardous material.

+ Provides technical support in site’s events associated to microbiology, projects and/or initiatives as required.

+ Gather information to complete the Environmental and Water Annual reports.

+ Act as Quality System Subject Matter Expert (SME) as assigned.

+ Participates actively in meetings associated with his/her area.

+ Performs special projects and other tasks as required and/or assigned by the Supervisor.


Requirements


+ Bachelor degree in sciences with concentration in Microbiology, Biology or Medical Technology.

+ Experience working in complex microbiological investigations and documentation in pharmaceutical environment.

+ Technical experience in the microbiology field supporting manufacturing and microbiology methods validation.

+ Two to three (2-3) years of experience in a microbiology laboratory environment.

+ Willing to work irregular and/or extended shifts.

+ Knowledge of pertinent regulations, particularity those related to the good manufacturing practices and good laboratory practices (including USP, EPA, JP, Safety Rules, OSHA rules, classical and modern analytical chemistry or microbiology, sophisticated instrumental techniques, and other applicable regulations).

+ In-depth knowledge of microbiology including aseptic techniques, sterility testing, environmental testing, LAL testing, microbiological testing of water, bioburden testing.

+ Ability to read and interpret documents such as safety rules, policies, manuals, and procedures.

+ Technical writing skills as well as experience reviewing microbiological procedures and technical investigation reports are a must.

+ Strong understanding of CFR 21, FDA and EU regulations among others.

+ Able to work in standing position for long period of time performing testing.

+ Able to handle laboratory equipment, tools and utensils.

+ Physical effort to handle laboratory equipment, solution containers, glassware.

+ Walk through the micro laboratory area.

+ Operate laboratory equipment.

+ Visual capacity to perform micro testing is required.

+ Able to visually differentiate.

+ Adequate odor perception.


Eligibility Requirements


+ Must be legally authorized to work in the United States without restriction.

+ Must be willing to take a drug test and post-offer physical (if required).

+ Must be 18 years of age or older.
All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

About the Company

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Boehringer Ingelheim