Job Description:
- Develop protocols for Environmental Monitoring and Process Qualification (EMPQs), Equipment and Maintenance procedures specific to pharmaceutical production
- Review Environmental Monitoring (EM) Trend Reports to identify trends and deviations pertinent to pharmaceutical manufacturing
- Analyze laboratory data and conduct comprehensive investigations into any discrepancies, ensuring compliance with regulatory standards
- Maintain meticulous logbooks detailing experimental procedures and results related to pharmaceutical production
- Perform data analysis to support decision-making processes and continuous improvement initiatives
- Possess familiarity with conducting and overseeing smoke studies and media fill procedures in the context of pharmaceutical manufacturing
Qualifications:
- Bachelor’s degree in Microbiology, Biology, or related field
- Minimum of 5 years of relevant experience in a pharmaceutical or biotechnology setting, preferably specializing in pharmaceuticals
- Proficient in protocol writing and documentation management within pharmaceutical manufacturing
- Strong understanding of regulatory requirements governing radiopharmaceutical production, including FDA guidelines and cGMP regulations
- Exceptional analytical and problem-solving skills, with a keen attention to detail
- Ability to thrive in a fast-paced environment, working independently and collaboratively to achieve team objectives
- Experience with smoke studies and media fill procedures in the context of radiopharmaceutical manufacturing is highly desirable
On-Site: Senior Microbiologist (3) (234597)
