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Consumables Production Lead - 2nd Shift

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Job Ref:
2154788
Location:
1001 Pawtucket Blvd, Lowell, MA
Category:
Consumables Manufacturing
Employment Type:
Full Time

Winning the race to bring new healthcare products safely to market drives Rapid Micro Biosystems (RMB) to combine today’s innovative technologies as never before. Your career at RMB puts you at the center of diverse global teams that span robotics, AI, Machine Learning, imaging, microbiology, and more, re-shaping how urgently needed pharmaceuticals are made, tested, and released for decades to come. The sky’s the limit.  

Careers at RMB are fast-moving, with the high growth you’d expect from a world leader in microbiology automation. Advancement at RMB affords an opportunity to achieve your personal goals and develop your passions, in an inclusive environment where every employee has the resources and opportunities to hone their skills. You’ll do more, learn more, and can make a profound impact on our business.  

The Consumables Production Lead will be a highly skilled production operator which will include ensuring that we meet the demand for products, production quality levels and production yield goals while maintaining cost control. This position will require being able to lead the production team and perform all duties that are required within the production area. Must be a self-starter who is comfortable working in a dynamic, team-based environment to reach common objectives with aggressive schedules. The hours for 2nd shift are 4:00 PM to 2:30 AM EST. 

Reports to Manufacturing Manager – Consumables.

Duties and Responsibilities:

  • Works in a safe manner and follows safety rules at all times.

  • Ability to problem solve and communicate issues/resolutions to production management.

  • Understands, undertakes and implements quality control/assurance techniques and procedures.

  • Ability to work with minimal supervision, supports and drives process improvements and team culture.

  • Follows procedures to ensure production of quality product.

  • Completes procedures and documents in accordance with good manufacturing procedures.

  • Generates product labels to meet production demand.

  • Adheres to production schedule and pacing targets.

  • Posts metrics.

  • Ensure that materials are stocked, kitted and prepared for the production day.

  • Requires the use of step stool or mobile stairs to reach above 6 feet.

  • Performs surface cleaning of equipment in preparation for daily production.

  • Inspect and ensure that all equipment is calibrated and in working order; balances/scales, pipettes, mediaclave, water purification systems, etc.

  • Sanitation and autoclaving of all media production equipment and areas prior to and following production work.

  • Performs aseptic techniques while following the SOPs.

  • Documents lot numbers, calibration and serial numbers of all equipment used as well as any pre-fill QC; pH, temperature, water resistivity, TOC levels, etc.

  • Completes batch process records and ensure they are correct and complete.

  • Assist with the execution and documentation of IQ/OQ and PQ processes.

  • Maintain and post manufacturing metrics.

  • Perform work that is compliant with cGMP, ISO, QMS and other pertinent regulations and directives.

  • Support immediate supervisor/manager and peers by anticipating problems, providing input on solutions, reacting productively to change and handling other tasks as assigned.

  • Monitor and react to multiple simultaneous machine sub-operations

  • Supporting new equipment installation and validation

  • Documentation of production runs

  • Assistance with development/construction/debug of new equipment

  • Other tasks as necessary to keep our equipment operating as efficiently as possible

  • Supporting new equipment installation and validation

  • Documentation of production runs

  • Assistance with development/construction/debug of new equipment

  • Other tasks as necessary to keep our equipment operating as efficiently as possible

  • Able to reconcile PHR’s in timely/daily basis

  • Able to process transactions in SAP on a daily basis

  • Able to do shift startups and shift shutdowns

  • Ability to assign work to team according to priorities

  • Ability to send out daily shift reports with accuracy of issues and performance

  • All other duties assigned by Manager.

Qualifications/Experience:

  • HS diploma and 2 years’ experience or Associates degree.

  • Experience with automated manufacturing processes is a plus.

  • Ability to perform simple maintenance and troubleshoot automated equipment a plus.

  • At least 1 year of clean room experience required.

  • Excellent aseptic process/laboratory skills.

  • Working knowledge of cGMP and ISO guidelines. Familiarity with FDA regulations a plus.

  • Ability to adhere to a production schedule

  • Ability to work overtime (off schedule and/or periodic weekends)

  • Ability to lift up to 50 lbs.

  • Ability to gown and follow clean room protocol.

  • Ability to work within a clean room for extended periods.

  • Requires the ability to multi-task and maintain focus.

ABOUT RAPID MICRO BIOSYSTEMS:

Rapid Micro Biosystems creates, sells, validates, and services innovative products for fast, accurate, and efficient detection of microbial contamination in the manufacture of pharmaceuticals, biologics, biotechnology products, medical devices, and personal care products.

The company’s Growth Direct™—the first and only growth-based system to automate rapid compendial QC Micro testing—ensures data integrity, compliance, and operational efficiencies driven by rapid methods and automation.

Rapid Micro Biosystems is dedicated to providing groundbreaking technology and products to support companies in their journey to achieve greater reliability, efficiency, and better predictability, ultimately providing higher quality products for improved patient outcomes.

Rapid Micro Biosystems is headquartered in Lexington, Massachusetts.  Our research & development, and manufacturing operations are located in Lowell, Massachusetts. Additionally, we maintain field offices in Freising, Germany; Switzerland, and Singapore. 

Equal Opportunity:

Rapid Micro Biosystems is committed to the principle of equal employment opportunity. Applicants for employment and employees are reviewed on their individual qualifications for a position. Under no circumstances will Rapid Micro Biosystems discriminate against qualified persons on the basis of race, color, religious creed, retaliation, national origin, ancestry, sexual orientation, gender identity, disability, mental illness, genetics, choice of health insurance, marital status, age, veteran status, or any other basis prohibited under applicable law.

Please no phone calls or agencies, please.

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