Manager, Engineering

Do you want to contribute to a larger purpose to save the lives of infants in the NICU? This is Prolacta Bioscience's mission! Take a look at this opportunity with our Engineering Team, which is seeking a passionate individual, to fill the role of our Manager, Engineering. This role will oversee the process and equipment design for the company as well as manage a group of technical engineers in an FDA environment.

Who Is Prolacta Bioscience?

We give babies a brighter future by unlocking the biological power of human milk. Established in 1999, Prolacta Bioscience is a privately held life sciences company that has touched the lives of more than 100,000 premature infants globally. Prolacta is the world's leading hospital provider of 100% human milk- based nutritional products. Based in Southern California, we employ more than 300 people globally, many of whom have dedicated their lives to neonatal care.

For more information, please visit www.prolacta.com

How you will contribute

This role will provide you with the opportunity to contribute to the growth of our organization and develop your professional skills by...

• Managing a team of technical Process/Project engineers.
• Overseeing technical engineering resource driving major capacity and process improvement changes impacting the manufacturing department.
• Designing and executing studies independently by assessing the technical scope and composing DOE design space (eg. equipment setup, data collection, sample submission, sample testing, and others).
• Authoring technical documentation (eg. studies, protocols, and reports) for material and technology evaluation, process improvement, and equipment qualification.
• Implementing material, equipment, and process changes through Change Control and Document Change Request processes.
• Leading the execution of capital equipment projects from installation through implementation.
• Serving as a Subject Matter Expert in all aspects of implementing new equipment from gathering requirement, vendor selection, FAT, SAT, IQ, OQ, and PQ.
• Interfacing with process and facility maintenance groups to support process equipment and critical systems uptime, including hands-on equipment troubleshooting (mechanical/electrical/controls).
• Leading investigations of manufacturing process/product non-conformances and contribute to the development of technical solutions to resolve issues.
• Leading technical problem solving sessions with cross-functional team to achieve Lean and efficient resolutions to manufacturing issues.

What you bring to the role

• Typical Education Level: bachelor's degree in engineering, (Electrical Engineering, Mechanical Engineering, Industrial Engineering, Manufacturing Engineering, or a related discipline) A minimum of a MS degree, Ph.D. preferably in Science or Engineering, Advanced degree can substitute for experience.
• Average years of experience: 10 years with 3 to 5 years in manager role (preferably)
• Managed technical staff / engineers.
• Experience with Six Sigma, Lean or other methodologies
• Highly skilled user of MS Excel, MS Access, and MS Project.
• Experience with GMP regulated environments, good documentation, quality systems and compliance experience required.
• Thorough experience integrating process control automation, including but not limited to: pneumatics, vision systems, instrumentation, and temperature controllers.
• Experience with the planning, specifications, validation, and administration of validated systems.
• Ability to work with multiple contractors and understanding of project pre-requisites and dependencies.
• Must be capable of working in an FDA regulated environment.
• Strong analytical skills, process orientation and teamwork.

How Prolacta benefits you

To drive the personal growth and business impact of our employees, we're committed to developing a supportive and enriching culture for everyone. From up to 100% healthcare coverage starting on your first day, to discretionary stock options and 401(k) match, we value our employees' health and financial wellbeing. We offer four weeks PTO during your first year of employment and support our new parents with a generous time-off program. We encourage employees to participate in our employee affinity groups, take volunteer time off, and provide access to different educational opportunities.

What else do you need to know

Location: City of Industry and Duarte, CA

Schedule: M-F 8am to 5pm

Travel: 20%

FLSA: Exempt

Depending on your residential location certain laws might regulate the way Prolacta manages applicant data. California Residents, please review our Privacy Notice for California Employees and Job Applicants for further information, this can be found on Prolacta.com on www.prolacta.com . By submitting your application, you are agreeing and acknowledging that you have read and understand the above notice.

Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to effectively communicate (e.g., talking/ hearing), walk, sit, use hands and fingers to handle, feel and reach things. The employee is occasionally required to taste, smell, stoop, kneel, crouch or crawl. Employee will frequently lift and/or move up to 50 lbs. Specific vision abilities required by this job include close vision, color vision and ability to adjust focus.

Sedentary to light work; repetitive motions; pushing; pulling; visual acuity to prepare and analyze data and figures, transcribe, view a computer terminal.

EEO Statement

"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

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