Bioprocess Specialist - CONTRACT

Responsibilities:

• Technical proficiency in aseptic techniques working with manufacturing equipment/instruments in open and closed systems   
• Organize, coordinate, and lead production activities and ensure execution of processes in production while strictly adhering to cGMP standards  
• Accurately complete batch records, forms, and documentation in line with Good Documentation Practices (GDP).  
• Work as part of a team to support the execution of daily GMP manufacturing activities.  
• Train staff in processing methods, aseptic technique, and cGMP clean room operations.  
• Review batch production records for completeness, accuracy, and to ensure cGMPs and Good Documentation Practices.  
• Initiate and support the closure of Deviation Reports and CAPAs  
• Other duties as assigned by management.  

Qualifications:

• Minimum High School diploma or equivalent experience is required. Associates or higher degree in Biology, Life Science, or Engineering is preferred.  
• 3-4 minimum years of experience in biotech or pharmaceutical manufacturing, preferably in a cleanroom environment.  
• Familiarity with cGMP standards and basic understanding of Good Documentation Practices.  
• Proficiency working in cGMP cleanrooms and aseptic techniques  
• Advanced understanding of pipetting and micro pipetting.  
• Demonstrated ability to identify, challenge, and implement potential improvements to work procedures.  
• Ability to work flexible hours, including nights and weekends, as schedules may shift in this start-up environment.  
• Ability to stand for extended periods and lift up to 20 pounds.  
• Strong communication and teamwork skills, with a willingness to learn.