Manufacturing Maintenance Supervisor

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 & Facilities team, which is seeking a passionate individual, to fill the role of our Supervisor, Manufacturing Maintenance. This role is responsible for leading day to day Maintenance functions required for the upkeep and reliability of equipment and facilities. These functions are performed while strictly adhering to current Good Manufacturing Practices (cGMP's), Environmental Health & Safety guidelines, and other regulations that apply.

The incumbent is responsible for leading the completion of daily maintenance and calibration activities in support of Prolacta's processes and operations. These activities include but not limited to preventative/corrective maintenance (internal and external contractors), calibration of instrumentation, utility support and facility responsibilities (fire, security, pest control, janitorial). This position requires teaching, mentoring and supervision of all levels of maintenance technicians.

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 performing the following duties...

SUPERVISION/MANAGEMENT

• Provides day-to-day supervision and critical decision making / troubleshooting for various equipment and facility activities performed by maintenance technicians and external contractors
• Communicates job expectations; planning, monitoring, and appraising job results; coaching, counseling, and disciplining employees; initiating, coordinating, and enforcing systems, policies, and procedures.
• Responsible for Human Resources tasks as is relates to the management of Non-Exempt employees per the Prolacta Handbook.
• Maintains staff by orienting, and training employees; developing personal growth opportunities.

SAFETY

• Ensures maintenance and repair activities are performed in a safe manner and follows all company Environmental Health and Safety (EHS) procedures.
• Maintains a safe and clean work environment by educating and directing personnel on the use of all control points, equipment, and resources; maintaining compliance with established policies and procedures.
• Manages external contractors with the same EHS expectations and regulations as internal Prolacta employees when they perform on-site work.
• Follow and comply with EPA, OSHA regulations with cGMP and compliance policies in mind.
• Identify areas requiring repair, or potential risks to product or employee safety.

MAINTENANCE PLANNING /SCHEDULING/SPARES

• Responsible for tracking and monitoring preventative/corrective/calibration maintenance work orders with the use of Computerized Maintenance Management System (CMMS)
• Coordinates maintenance and calibration activities with Maintenance planner for all equipment and facility assets. Includes maintenance planning, scheduling, (internal maintenance technicians and/or external contractors) monitoring and tracking of performance metrics and documentation management. These tasks will be coordinated in conjunction with Prolacta Manufacturing activities and production schedules
• Schedules and ensures completion of preventative maintenance of critical plant equipment on a regular basis. This maintenance includes the following types of equipment; bulk processing tanks, filling, packaging, CIP systems, facilities/grounds, critical systems/utilities and electrical control systems (i.e. electrical distribution, variable frequency drives, electric motors, instrumentation and electrical control systems)
• Develops and manages a spare part management system for all critical equipment/utility/facility spare parts needed to perform all required maintenance and support.

FINANCE

• Approve department related invoices for payment
• Develops capital memorandums / justifications / expenditures as required to perform capital projects
• Supports development of budget / forecasting activities and manages expenses throughout the year to uphold financial targets/metrics

TECHNICAL SKILL SETS/EXPERIENCE

• Ability to troubleshoot, diagnose, and repair of critical equipment including; process equipment, Programmable Logic Controls (PLC) driven equipment, critical systems, tanks pumps, aseptic filling and packaging equipment. Responsible for repairing and or replacement of the mechanical, electrical and controls components of Bulk processing tanks, filling, packaging, facilities, critical systems / utilities and electrical control systems as assigned.

• Requires familiarity with generally accepted building and electrical codes to include NEC and UMC in compliance with LA City. Maintain and repair facilities and equipment within applicable codes
• Support engineering projects including but not limited to: equipment installation, commissioning, and validation process. Work with various departments to schedule and execute installations. Work with contractors for larger scope items

QA / COMPLIANCE

• Manages Maintenance and Engineering SOPs and other documents related to maintenance responsibilities and procedures to ensure integration of cGMPs and improvements to process efficiency.
• Authors required documentation such as investigations, corrective actions, Out of Tolerance reports and various maintenance forms as it relates to maintenance and calibration activities.
• Assist and support Regulatory agency (internal and external) audits. Presenting department procedures and maintenance documentation (PMs, Calibrations, Work Request / Orders, etc...)

What you bring to the role

• High School diploma (minimum), associate degree (technical discipline) or advanced degree (Engineering, Operation management or life science is highly desirable). Education level will align with a combination of Journeyman training /certification and years of hands-on work experience.

• Minimum of 5 to 10+ years relevant experience in a health care product manufacturing environment or equivalent.
• Direct hourly supervision experience (maintenance / operations / warehouse) is preferred

• Previous experience in a pharmaceutical or highly regulated bioscience health care environment is preferred
• Knowledge of food / dairy, infant formula, pharmaceutical cGMP is a plus

• Knowledge of production equipment including but not limited to: process tanks, critical systems, ultrafiltration skids, separation equipment, filling and packaging equipment and CIP systems is preferable
• Knowledge of PLC based process control systems, instrumentation and mechanical equipment, such as controllers, indicators, control valves, analyzers, sensors, pumps, refrigeration systems, glycol, chillers, freezers and HVAC, etc.
• Ability to read, write and interpret technical documents, equipment manuals, instructions, electrical and mechanical drawings, equipment blueprints and piping and instrumentation drawings.
• Knowledge of cGMP and health care product manufacturing experience preferred

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 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: Duarte, CA

Travel: 0 to 25% travel mainly for training and equipment acceptance trips

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.

• Requires prolonged standing, crouching, or bending
• Requires gowning and repair of equipment in cleanroom environment
• Requires support and exposure to cold product freezer storage areas
• Requires lifting of materials weighing 50lbs or more
• Requires accessing and working on facility roof (climbing and exposure to heat)
• Use of ladders, forklifts, and scissor lifts

• Must be able to perform duties within clean rooms, requiring to push, pull, and lift equipment up to 50 pounds while full gowned on occasion.
• Work in -25 degree Celsius for short periods of time to manage maintenance work in the freezer on occasion.

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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