Laboratory Technician V - Microbiology
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Performs microbiological testing on raw materials, in-process and finished product samples. Requires thorough knowledge and technical expertise of Microbiology as well as regulatory requirements. May be responsible for leading a functional sub-team.
This position is responsible for the following:
- Performs microbiological validation and routine testing and interprets the results based upon Departmental Standard Operation Procedures.
- Responsible for writing OOL (Out of Limit Investigations), Protocols (Media Fill Specific), Technical Assessments, Final Reports and writing and/or revising SOP’s and risk assessments.
- Review and approve microbial testing and gamma sterilization records in order to ensure that the company is in compliance with all environmental, health and safety requirements.
- May perform laboratory equipment validations.
- May perform equipment calibrations.
- May assist with microbial investigations.
- May prepare trend analysis and reports.
- Perform any other tasks/duties as assigned by manager.
Incumbent has full authority to make decisions and/or take action that is required to carry out job duties. Internal requirements include compliance with ethics, environmental health and safety, financial, human resources, cGMP procedures, general business policies, requirements and objectives. The incumbent must be willing to take temporary assignments as required.
Regulated Responsibilities (including cGMP and EHS)
Incumbent is expected to be fully compliant with all criteria established by governmental agencies, Ministry of Health, and legislative requirements including, but not limited to: the FDA, European Community (EC), ISO 13485 - Medical Devices, European Economic Community Medical Device Directive (MDD), Canadian Medical Device Regulations (CMDR), OSHA, Sarbanes-Oxley, EPA, DOT, EEOC, and ADA.
Incumbent will work to ensure that the company is in compliance with all environmental, health and safety requirements and assure our business practices enhance the welfare of our customers, employees and the community in which we operate.
Education and Experience:
Minimum requirements for this position are:
Bachelor’s Degree in Microbiology or related biological science.
Five (5) years of experience in pharmaceutical manufacturing microbiology lab or similar laboratory experience preferred.
Experience working in a GMP regulated environment required.
Intermediate user knowledge of Microsoft Office. Experience with LIMS and Trackwise preferred.
Essential Knowledge, Skills & Abilities:
- Excellent analytical skills and problem-solving skills.
- Strong math skills, including the comprehension of metric weights and measures, performing complex calculations, and spreadsheet management.
- Ability to perform detailed tasks and document activities accurately.
- Able to work in an aseptic controlled environment which includes wearing PPE, aseptic gowning qualifications, and subsequent gowning requalification’s.
- Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts).
- Ability to work and communicate with others in a professional and effective manner, within a team-oriented environment.
- Ability to read, comprehend, write, and communicate effectively in English.
- Intermediate user knowledge and understanding of Windows based computer systems such as Microsoft Office, with an ability to learn other computer-based systems. Experience with SAP preferred.
- Strong written and verbal communication skills.
- Ability to work with minimal supervision.
- Ability to provide direction for functional area.
- Physically able to continuously stand and walk.
- Physically able to lift up to 40 lbs. for men and 35 lbs. for women.
- Physically able to bend, climb, lift, squat, stoop, and stretch to reach frequently.
Significant Work Activities
Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.