Prolacta is the pioneer in human milk-based nutritional products for premature infants in the neonatal intensive care unit (NICU). Prolacta believes that there is no adequate replacement for human breast milk and, as such, we believe infant nutritional products should be human milk-based. As a privately held, scientifically driven company, committed to improving premature infant nutrition, we are using human milk to change the standard of care in the NICU. Prolacta operates and/or owns milk banks that provide the starting material for the products Prolacta sells.
Job Summary
This entry level manufacturing position is responsible for completing Prolacta’s manufacturing processes while strictly adhering to current Good Manufacturing Practices (cGMP’s), Environmental Health & Safety guidelines, and other regulations that apply. The incumbent is responsible for following daily job assignments in support of the production activities. These activities include but not limit to manufacturing of bulk human milk concentrate, pasteurization and filling, labeling and packaging operation, and equipment cleaning. Other duties may apply.
Primary Duties and Responsibilities
• Ability to perform the following production activities without assistance.
o Thawing and pooling of raw milk
o Aseptic sampling
o Preparation of cleaning solutions
o Operation of mixers
o Operation of chart recorders
o Disassembly and assembly of process equipment
o Cleaning and sanitizing of Facility and Equipment
o General housekeeping
o Packaging of products.
• Assist in production activities such as:
o Milk separation
o Ultrafiltration
o Product formulation
o Filling machine operations
o Mineral addition
o Pasteurization
o Engineering studies for process improvement or troubleshooting
• Identify process improvement opportunities
• Maintain 5S in their work area
• Support problem-solving small group activities
• Occasional overtime which includes weekends.
• Adhere to departmental and corporate safety policies.
Job Requirements and Qualifications
• Follow approved procedures (SOPs), runsheet and forms to complete manufacturing operation
• Good oral and writing communication skill
• Knowledge of current Good Manufacturing Practices including Good Documentation Practices
• Understanding of General manufacturing process, control of time, speed, temperature, pressure, etc)
• Timely report of non-conformance and follow escalation procedure
• Ability to operate and maintain in a safe working environment.
• Perform all work in a clean room (sanitized) manufacturing environment.
• High School diploma or equivalent
• Minimum of 1 year Prolacta Operation experience, or 2 years of manufacturing technician in a similar health care manufacturing environment.
• Basic manufacturing GMP practice
• Simple manufacturing equipment operation and adjustment
• Equipment assembly, disassembly, and cleaning
• Clean room technology (people and material flow, cleaner and disinfectants, air flow, basic hygiene)
• Good computer skills
Other Knowledge, Skills and Abilities
Interpersonal Skills
Good team spirit, positive attitude. Shows a willingness to work effectively with others.
Accepting Direction;
Accepts and follows directions from leads/management; respects authority; complies with request; does what they are asked to do.
Performs to required standard, owns mistakes and uses them as opportunities for learning and development. Flexes as needed. Accepts constructive feedback and/or consequences without making excuses or blaming others first.
Work Environment (Location, travel, shift, on-call, etc.)
City of Industry
Physical Requirements
• Must be able to perform duties within clean-rooms, requiring to push, pull, and lift equipment up to 50 pounds while full gowned.
• Work in ≤ -25 degree Celsius for short periods of time to retrieve raw and finished material from the freezer.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
“Prolacta Bioscience, Inc. is an Equal Employment Opportunity Employer.” Prolacta Bioscience, Inc. is committed to a proactive program of affirmative action and diversity development. The Company will continue to recruit, hire, train, and promote into all job levels without regard to race, religion, gender, marital status, familial status, national origin, age, mental or physical disability, sexual orientation, gender identity, source of income, or veteran status.