Remote: Contamination Controls Strategy (232846)

Life Sciences & Technology

Project Description:

The Contamination Control Program Expert will be provide leadership, strategies and guidelines for the client’s Contamination Control Program (CCP) and microbial control strategy initiatives. This role will lead the site contamination control strategy and quality risk management (QRM) initiatives designed to develop a robust microbial control strategy at the site. This role will also lead and/or support investigations related to microbiology. The individual will work closely with stakeholders in manufacturing, quality assurance, engineering, validation, and facilities to drive alignment to site and global contamination control goals and improvement initiatives. This role will also support new product transfers coming to the site related to contamination control aspects of manufacturing process and equipment design, microbial method validations and rapid microbial methods

Skill, Experience Level, & “other” Background Requirements:

Bachelor’s degree or equivalent experience in Microbiology or Biology or Science and 10+ years of relevant experience in commercial biotechnology or pharmaceutical production managing projects
Working knowledge of microbial risk assessments HACCP/FMEA is desirable
Strong knowledge of cGMPs and applicability to manufacturing operations in a biologics environment is preferred.
Experience in cell and gene therapy and/or Rapid Micro Methods (RMM) is preferred.
Strong knowledge of Lean/Six Sigma and the DMAIC problem solving process is required. Green belt training/certification desired.
Working knowledge of Quality by Design (QbD), Quality Risk Management (QRM), is preferred.

Other Important Information (i.e. Security Clearance, Business Travel, Expenses, Overtime, W2 Only, etc.):

Some travel may be required

Remote: Contamination Controls Strategy (232846)




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
Remote, United States

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