Piramal Pharma Solutions
Microbiologist II
Lexington,KY, USA · Mid
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About the role
- Be the First to Apply Division Piramal Pharma Solutions Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle.
- We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.
- This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms.
Responsibilities
- Develop microbiological test methods and method validations.
- Perform microbiological testing of raw materials, work-in-process, and finished product for product approval and release.
- Perform growth promotion of media and maintenance of bacterial cultures.
- Provide support to facility to resolve nonconformance issues and identify corrective and preventative actions as related to environmental monitoring excursions
- Complete environmental monitoring and laboratory related investigations and properly document results.
- Maintain GMP/GLP documentation relevant to the duties and responsibilities assigned.
- Interact and coordinate activities with other departments and external vendors to support and meet the facility goals and objectives
Requirements
- 2+ years of practical laboratory experience in a manufacturing environment
- Experience with general documentation practices and GMP compliance with data entry forms with specific attention to details
- Experience with common microbiology lab instrumentation is a requirement, especially with autoclaves, air samplers, light microscope, biohazard cabinets and water purification system.
- Practical hands on experience with basic lab equipment such as pH, balances, water baths and other equipment common to microbiology methods.
- Knowledge of cGMP's and understand the pharmaceutical industry expectations
- Intermediate proficiency in MS Office (i.e. MS Word, MS Excel, Access, Outlook)
- Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.
- B.S. in Microbiology, Biology, Life Sciences, or related field
- Working knowledge and practical experience with good laboratory practices in a microbiology lab environment and competency with microbiology techniques such as Gram staining, isolation plating, media preparation and microorganism identification methods
- Must understand basic lab safety, bio-hazard and chemical waste disposal practices
This listing is sourced directly from Piramal Pharma Solutions's careers page and normalized into a canonical job model.