Bioprocess Specialist - CONTRACT

The Bioprocess Specialist II plays a critical role in the cell and gene therapy manufacturing processes at GeneFab. This position involves executing both upstream and downstream processes in a GMP-compliant cleanroom environment, with responsibility for troubleshooting, deviation management, training, and contributing to 5S and other improvement initiatives with the goal of ensuring on time delivery and right first-time execution of Manufacturing batches. You will collaborate with Operations, MSAT, Quality, and Facilities teams to ensure consistent production outcomes.

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.