Manufacturing Technician I - Live Downstream

Job Summary and Purpose

The Live Downstream Lab Technician I will work directly with a range of equipment including batching vessels, filling machines, capping machines and lyophilizers. The Live Downstream Lab Technician I will work directly with live antigen, batching solutions and semi-finished products following aseptic technique and cGMP procedures.

Responsibilities and Key Duties

• Set up and turnaround of all process equipment
• Work with chemicals, steam, and pressurized vessels
• Operation of batching vessels, filling machines and capping machines
• Perform environmental monitoring during aseptic procedures
• Use aseptic technique during processes
• Perform APHIS certified sampling procedures
• Operate general production equipment such as autoclaves, pumps, scales, particle monitors, etc.
• Prepare solutions
• Perform daily cleaning and sanitation laboratories and equipment
• Assemble batching and filling equipment for use in processes
• Follow standard operating procedures (SOPs)
• Document and maintain activity records according to cGMP regulations
• Maintain an effective working relationship with others
• Perform all other duties assigned
• Utilize acceptable PPE and follow safety procedures

Core Competencies

• Solutions out of complexity - Work and evolve with immediate environment
• Client focus - Make sure needs and requests are treated equally and in a positive way
• Collaborate with empathy - Fully take part in the working group to share information, listen to others and have a clear idea of the decisions taken
• Engage and develop - Open to share knowledge and to receive feedback from others
• Drive ambition and accountability - Ensure accuracy of work with the use of KPI's and a responsible commitment
• Influence others - Show structure, confidence, and an ability to synthesize while speaking

Technical / Functional Competencies

• Excellent writing and communication, interpersonal and organization skills
• Good self-discipline and attention to details
• Must follow proper documentation procedures
• Must be able to work both independently and in a fast pace team environment
• Good math and computer skills
• Must have flexible work hours, and be willing to work outside of normal, scheduled hours; as necessary
• Must be able to work alternative shift hours and weekends as required
• Must possess planning and time-management skills
• Excellent communication skills, both written and verbal
• Demonstrated basic mechanical aptitude and problem solving skills

Qualifications

• Education - Associate/Bachelor's degree in Life Science preferred but not required
• Work Experience - Experience in a cGMP environment is preferred
• Knowledge of cGMP and CGLP procedures is desirable
• Experience with Lean Manufacturing is preferred

Physical Requirements

• Ability to read, write legibly and understand English
• Color vision, frequent fine motor movements of the hands and wrist, periods of short term balancing, bending, stooping, squatting, twisting and reaching below knees to above shoulders
• Ability to stand and walk >90% of work day
• Ability to push/pull 50 lbs, up to 120 lbs occasionally
• Ability to lift up to 35 lbs overhead, up to 50 lbs overhead occasionally
• Ability to carry up to 50 lbs
• Ability to get up from seated on the floor to standing without assistance
• Ability to dress and operate in clean room environments
• Daily dressing and operating in clean room required garments
• Employees must adhere to strict grooming and appearance standards. The wearing of makeup, visible piercings, false nails, nail polish, and any form of jewelry is strictly prohibited while on duty

Working Conditions

• Must be able to tolerate cold working areas