Process Engineer II - Internal Applicants only

This posting is intended to for Internal Prolacta Employees only.

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 Facilities team, which is seeking a passionate individual, to fill the role of our Process Engineer II. This role is a technical role with emphases in product and process understanding and process improvement.

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...

• Service as technical engineering resource in support of Manufacturing department in areas of Bulk, Filling, and Packaging processes.
• Interface with process and facility maintenance groups to support process equipment and critical systems uptime.
• Engage in hands-on equipment troubleshooting (mechanical/electrical/controls).
• Develop and prepare technical documentation (eg. studies, protocols, and reports) for material and technology evaluation, process improvement, and equipment qualification.
• Execute studies by following written instruction (eg. equipment setup, data collection, sample submission, sample testing, and others).
• Implement material, equipment, and process changes through Change Control and Document Change Request processes
• Coordinate and execute equipment Factory Acceptance Test at vendor sites.
• Coordinate and execute equipment installation, Site Acceptance Test, and engineering commissioning.
• Execute equipment Installation, Operational and Performance Qualification.
• Provide tactical support of manufacturing process/product non-conformances and develop technical solutions to resolve issues.
• Lead technical problem solving sessions with cross-function team to achieve Lean and efficient resolutions to manufacturing issues.
• Utilize DMAIC methodology in process improvement projects.
• Track and evaluate the yield performance of manufacturing process.
• Perform analysis using statistical software (eg. Excel, Minitab) to understand and interpret data, and present technical conclusions.
• Provide technical solutions to R&D department for projects or continuous improvement ideas.
• Provide technical support to Validation department for Process Performance Qualifications.

What you bring to the role

• Bachelor of Science in Engineering Discipline (Mechanical/Chemical/Biomedical Engineering) or Biological Science with work experience. Masters of Science in Engineering Discipline or Biological Science with limited experience.
• 3 to 5 years in an engineering or biological related field
• Knowledge of cGMP and experience working in cleanroom systems is a must
• Basic knowledge of Six Sigma, DMAIC, and Lean principles
• Knowledge of automated manufacturing equipment design and operating principals
• Knowledge of equipment emergency, preventative, and corrective maintenance strategies
• Knowledge of equipment and process qualification strategies
• Hands-on experience with process tanks, mixers, separators, ultrafiltration, liquid processing, and process automation in a manufacturing environment
• Hands-on experience in continuous improvement project leadership
• Strong PC skills with MS Office Suite, Minitab

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, CA

Schedule: Mon-Fri, 8-5

Travel: less than 5%

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 25 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