Sr. Manufacturing Technician; Onsite

Senior Manufacturing Technicians are involved in cleaning and sterilization of process equipment and supporting cGMP operations. Upstream staff focuses on supporting fermenters and filtration equipment, Downstream staff focuses on supporting HPLC and low-pressure Chromatography equipment.

• This position is responsible for performing a variety of manufacturing tasks under general guidance and in accordance with current GMPs.
  
  Responsibilities include:
• Operates process equipment such as fermenters and chromatography systems in accordance with established Standard Operation Procedures (“SOP”s)
• Operates support equipment such as autoclaves, media and buffer preparation equipment in accordance with established SOPs
• Performs clean-in-place and steam-in-place operations to prepare equipment for manufacturing operations in accordance with established SOPs
• Media/buffer compounding (weighing, measuring, mixing, filtering)
• Filter wetting and integrity testing
• Stocking of materials and equipment
• Performing basic maintenance of equipment
• Maintains tidiness of area
• Adheres to all applicable regulations and requirements including compliance with internal SOPs, GMP, Health and Safety, WISHA/OSHA, regulatory compliance, company policies, and employment-related laws and statutes.
• Successfully completes all mandatory Quality and Compliance training within required time frames.
• When the facility is not actively manufacturing Leukine, the technician will be responsible for the following:
• Revision of controlled documents
• Maintaining training and acquiring new skills
• Performing routine maintenance on Manufacturing equipment and systems

• Ability and willingness to wear a respirator and other PPE for multiple consecutive hours while meeting compliance and safety guideline to complete certain tasks.
• Ability and willingness to work with strong acids, bases, and other solvents required for the job (PPE utilized).
• Meets training and qualification requirements, including proficiency assessments.
• Ability and willingness to follow directions from others (i.e., peers, lead, supervisor).
• Possesses effective problem solving and teamwork skills.
• Recognizes severity of issues and escalates to a Supervisor or higher level co-worker as appropriate.
• Utilizes manufacturing knowledge to improve operations and affect positive change.
• Excellent soft skills including a bias towards action, the ability and willingness to give and receive constructive feedback, is comfortable working within a diverse team and across multiple functions, exhibits a consistently constructive attitude, and is adaptable and at ease with handling unexpected changes and challenges.
• Solid English language communication skills, both oral and written, are required for this highly collaborative role. Willingness and ability to clearly express opinions and ask questions. Comfortable actively participating in cross-functional meetings.
• Proficiency with MS Office products including Word and Excel necessary; ability and willingness to quickly adopt other job-specific applications will be necessary.

• Experience in Fermentation/Upstream (microbial fermentations, filtration equipment) and/or Downstream experience (HPLC and low-pressure Chromatography)

• High School Diploma or GED
• 2 + years of relevant work experience. Some work experience can be substituted/augmented with achievement of a relevant certification in biopharmaceutical manufacturing program, an associate or bachelor's degree from an accredited institution.

• Associate degree, BA or BS in a science-related field or Engineering Field.
• Experience in a cGMP manufacturing environment or other comparable experience (i.e., other…