Manufacturing Associate II

Primary Responsibilities

• Manufacture cell culture products according to manufacturing batch records while ensuring compliance with quality standards, company policies, and current regulations.
• Perform cleanroom operations, adhering to aseptic processing controls, including gowning and cleaning procedures.
• Document manufacturing procedures (e.g., SRs, EPRs, BRs) in compliance with Good Documentation Practices (GDP) at the time of execution.
• Ensure proper issuance and accountability of items used in manufacturing records (SR, EPR, BR).
• Demonstrate and apply knowledge of current Good Manufacturing Practices (cGMP) in daily tasks and responsibilities.
• Maintain and uphold 5S standards in the manufacturing environment.
• Operate and perform maintenance on equipment per applicable Standard Operating Procedures.

Minimum Requirements

• Manufacturing Associate 1: Bachelor's degree in a related scientific or engineering discipline with 0-2 years of GMP manufacturing experience; OR high school diploma with 3-5 years of related GMP manufacturing experience.
• Manufacturing Associate II: Bachelor's degree in a related scientific or engineering discipline with 2-5 years of GMP manufacturing experience; OR high school diploma with 4-6 years of related GMP manufacturing experience.

Language Ability

• Fluent in English language both reading and writing.
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, procedure manuals, batch and production records.
• Ability to write routine reports and correspondence.
• Ability to speak effectively before groups of employees of organization.

Reasoning Ability

• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Math Ability

• Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
• Ability to compute rate, ratio, and percent and to draw and interpret graphs.

Physical Demands

• Standing and sitting for long periods of time may be required at times.
• Lifting, pushing, and pulling may be required for stocking and movement of equipment.
• The use of ladder may be required when setting up bioreactors.

Working Conditions

• The job requires working 12-hour shifts which may include working overnight.
• The job requires working within a cGMP manufacturing biotechnology facility which requires clean room operations.
• Clean room operations require donning clean room attire when entering clean room areas and maintaining good personal hygiene.
• While performing the duties of this job the employee regularly utilizes equipment and materials which include mechanical hazards, chemical hazards, electricity hazards, and tripping and falling hazards.
• The noise level in the environment is moderate to high.

Essential Physical Functions

• Staff will stand throughout facility to various locations during production activities and within production rooms in order to accomplish production tasks.
• Staff will walk throughout facility to various locations during production activities and within production rooms in order to accomplish production tasks.
• Staff will perform activities such as training, document review, and other computer work, as required.
• Staff will lift and carry 20kg bags of WFI, Buffer and Media within facility, as needed.
• Staff will push 200kg drums of WFI, Buffer, and Media throughout facility, as needed.
• Staff must perform some operations on ladders or step stools.
• Staff must perform some operations on ladders or step stools.
• Staff must perform some operations on ladders or step stools.
• Staff must be able to reach underneath production equipment for bioprocess container installation and inspection.
• Staff must be able to reach underneath production equipment for bioprocess container installation and inspection.
• Staff must be able to reach underneath production equipment for bioprocess container installation and inspection.
• Staff must be able to reach underneath, over, and within production equipment for bioprocess container installation, inspection and use.
• Staff must be fluent in English language.
• Staff must be able to speak with other staff over radios, cell phones, and within production locations over machine noise.
• Staff will read production instructions to others and appropriately understand instructions.
• Staff must be fluent in English language.
• Staff must be able to hear other staff over radios, cell phones, and within production locations over machine noise.
• Staff will listen to other staff during reading of production instructions and appropriately understand instructions.
• Staff must be able to read manufacturing procedures and execute production activities.