Company

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

Validation Engineer II is responsible for the day to day functions related to the qualification and/or validation of equipment, raw materials, and cleaning processes. This position will typically focus on three or more validation projects at a time.

Under a minimum supervision, the candidate will be responsible to provide:

Primary Duties and Responsibilities

· Write, execute, and summarize qualification and validation reports

· Plan for execution of validation protocols and studies

· Investigate, assess and develop new cleaning cycles

· Train personnel on system operation

· Use technical problem solving techniques for solving basic equipment issues

· Perform validations and studies in a safe, compliant manner

· Review, author and approve quality related documents as needed

· Support process development and/or validation

· Perform risk assessment activities

Job Requirements and Qualifications

Educational Preference

· Bachelor of Science in Engineering Discipline (Mechanical/Chemical/Industrial Engineering) or Science

Experience Preference

· Experience with equipment qualification and cleaning validation (3 to 7 years)

· May require prolonged standing during execution of studies

· Requires gowning in controlled environments and cleanrooms

· Requires general mechanical inclination

· Requires lifting of materials up to 50 lbs.

· Knowledge of cGMP and cleanroom system is a must

· Strong PC skills with MS Words, Excel, PowerPoint, Visio, Project, Minitab

Other Knowledge, Skills and Abilities

· Requires Technical Writing Competency

· Ability to communicate effectively at all levels in verbal and written form

· Capability to read, redline equipment P&ID and facility layout drawings

· Computer skills (Word, Excel, Project, Visio)

· Capable of working in team environment, or unsupervised

· Applied knowledge of project management

· Experience working in a Pharma, Biologics, Infant Formula or similar environments

· Experience working in a cGMP environment

· Knowledge of basic laboratory and pharmaceutical production equipment including but not limited to: process tanks, filtration systems, analytical equipment, filling units, and CIP systems

· Positive attitude and motivated Self Starter

· Produce and present clear, concise and professionally written communications and presentations

· Must be able to work under pressure, meet deadlines, and be flexible when working on multiple projects simultaneously

· Strong Continuous Improvement and Troubleshooting mindset

· Capable of making quick and sound decisions

· Results oriented

· Good interpersonal skills

o Candidate will work with production personnel, supervisors and managers

Work Environment (Location, travel, shift, on-call, etc.)

Travel

<5%

Location

City of Industry, California

Duarte, California

Direct Reports

N/A

Disclaimer

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.