On-Site: Senior Microbiologist (3) (234597)

Life Sciences & Technology | Validation
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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)

About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Start Date
ASAP
Location
US On-Site

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