About this role
- 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.
- 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.
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