About this role
Company Description
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions 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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.
Job Description
- Perform a range of microbiological testing activities to support product release and site compliance, including:
Environmental Monitoring (EM)
- Water Sampling
- Bioburden Testing
- Endotoxin Testing
- Growth Promotion Testing
- In-Process Testing
- Sterility Testing
- Antimicrobial Preservative Effectiveness Testing (APET)
- Antibiotic Assays
- Generate accurate and timely technical reports and test documentation.
- Draft, review, and maintain quality documentation, including:
Standard Operating Procedures (SOPs)
- Protocols
- Training Materials
- Investigation Reports
- Corrective and Preventive Actions (CAPAs)
- Deviations
- Trend and analyse microbiological data, investigating adverse, atypical, and out-of-specification (OOS) results as required.
- Support validation and qualification activities for microbiology laboratory equipment and test methods.
- Ensure all testing activities are performed in compliance with cGMP, regulatory requirements, and site quality standards.
Qualifications
- Third-level qualification in Microbiology , Biological Sciences , or a related scientific discipline.
- Minimum of 12 months' experience within a regulated manufacturing environment, preferably in aseptic pharmaceutical production .
- Strong working knowledge of the pharmaceutical industry , including sterile manufacturing processes and GMP requirements.
- Practical experience in aseptic processing , contamination control, and microbiological laboratory techniques.
- Demonstrated understanding of microbiological testing methods, environmental monitoring, and sterile operations.
- Strong technical, analytical, and problem-solving skills, with the ability to investigate and resolve microbiological issues.
- Experience working within a highly regulated environment, with a commitment to quality, compliance, and continuous improvement.
- Excellent communication, documentation, and report-writing skills.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html